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Sandeep Singh Dhillon
Sr. Manager, R&D at Germer International Billings, MT (
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About the Job

Do you love being outdoors and want to get away from the hustle and bustle of a larger town??? If so, you may be interested to know that Germer International has a client located in one of the most beautiful parts of the country where those outdoor recreational activities is available to you right outside your front door. A growing API manufacturing organization located in the Midwest is seeking an expert Process Development Scientist who has industry experience in overseeing a team of R&D Scientists (both Analytical Development and Process Development) to come aboard and join their team. The Sr. Manager, R&D will be involved in the tactical responsibilities of overseeing and developing staff in the lab while working closely with the VP, Product Development in tackling process improvement initiatives and pipeline development.

What does this mean to you????

·An opportunity to lead, mentor, and coach the R&D department consisting of skilled and experienced Scientists in the industry (mainly PhD-level)

·An opportunity to work in a smaller environment that brings a strong family feel and where the team mentality is a strong aspect of the company culture

·Outdoor recreational activities (hiking, horseback riding, camping, fishing, etc…) are right at your fingertips

·Competitive salary, bonus, & relocation assistance provided

Essential Duties and Responsibilities

Provide guidance and oversight to ensure that newly developed manufacturing and product testing processes are state-of-the art, cost-effective, robust, and well-defined.
Through resource and long-term planning, ensure that R&D resources are allocated appropriately to support company goals and long-term strategy, that project deliverables are met, and that development is completed in accordance with ICH Q11 and company policies.
Interact effectively with cross-functional teams, including Project Management, Product Development, QC, QA, Operations and other internal and external development groups.
Conduct patent reviews and work with patent attorneys to ensure that future processes will have freedom to operate and that newly developed IP is appropriately protected.
Conduct feasibility analyses to determine optimal processes for further development.
Write, review, and/or approve scientific documentation, including development reports and regulatory documents in accordance with company policies.
Perform complex laboratory activities including planning and performing experiments, including Design of Experiments, and research for novel processes to produce APIs.
Ensure that analytical test methods used in R&D are scientifically sound and suitable for their intended use throughout the development process and that test methods intended for transfer into QC are able to be validated in accordance with ICH requirements.
Conduct troubleshooting, participate in risk assessments, and provide technical assistance for NPD project teams, Operations, and Quality Control.
Ensure that the R&D laboratory has supplies and organization to perform the assigned work, and is operated in accordance with OSHA, cGMP, DEA, and company policies.


·Ph.D. in Chemistry required; with at least 10 years of organic synthesis experience including at least 10 years in a leadership role.

·At least 5 years of experience in analytical method development and validation preferred.

·Research and Development experience in the pharmaceutical industry, specifically in the development of active pharmaceutical ingredients, strongly preferred.

Please apply at

Sandeep Singh Dhillon
Senior Analytical Development Scientist at Germer International Cedar Rapids, IA (
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About the Job

Our Client is a $300MM Pharmaceutical organization who has shown continuous success and improvement throughout their years of operation. Their serious commitment to high-quality standards has been proven through the products & services they provide via one of their manufacturing facilities, located in the Midwestern region of the US. They continue to strengthen that commitment through acquisitions and expansion projects across all of their domestic and international sites. Their mission is to continue to being aboard experienced professionals within the Pharmaceutical industry to oversee core elements of their operation. They are currently seeking Sr. Analytical Development Scientists who will provide technical support and leadership to multiple project teams. The Senior Analytical Chemist will evaluate and interpret analytical results, develop, validate and transfer analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks.

Job Responsibilities

With minimal supervision, safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products.
Investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
Perform analytical chemistry assays based on new and existing methodologies
Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
Write technical reports to document analytical methods
Maintain laboratory notebooks documenting work
Maintain compliance with GMP SOPs and DEA regulations
Transfer documented analytical methods to the QC and Process Support Group departments
Set up new or existing analytical methods for compound identification, purity and potency testing.
Coordinate off-site testing as necessary
Conduct testing of analytical samples for the Chemical Development Department as necessary.
Qualify reference materials.

Job Qualifications

Advanced Chemistry degree desired, with a PhD preferred
Minimum BS degree in Chemistry or closely related field required, with 7+ years of experience in manufacturing support laboratory
Experience with dissolution and chemosensory testing highly desired
Familiarity with compliance requirements within cGMP, safety and regulatory environments
Operational knowledge of analytical instrumentation like HPLC, GC, GC-MS, FTIR, UV-VIS equipment, and data stations required
Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment
The ability to solve extremely complex problems where analysis of situations or data requires an evaluation of intangible variables
Ability to work in a highly independent and self-directed work environment.

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Sandeep Singh Dhillon
Engineering Manager (Pharmaceutical Industry) at Germer International Buffalo, NY (
Pharma Job Portal

About the Job

Germer International’s client, a $6B Pharmaceutical organization already recognized as one of the top three pharmaceutical companies manufacturing generic controlled substance sterile injectable products here in the US, is actively looking to expand their engineering team. Due to major growth of their organization, they are greatly expanding their state-of-the-art facility and need qualified Pharmaceutical Engineers who understand sterile operations to come aboard and join their team. They are actively looking foran Engineering Manager who will be responsible for managing the engineering team as well as engineering functions including plant engineering, project management, and computer aided drawing and design. The team will comprise of Manufacturing and Project Engineers, CAD personnel, Technical Writers, Mechanics/Electricians, and Administrative staff who will work together to improve plant quality, operational efficiency/effectiveness, capacity, capability, and modernization objectives.


Responsible for the design, procurement, installation, and improvement of site manufacturing and utility equipment as well as facility upgrades and expansions in a cGMP environment.
Responsible for the design, fabrication/construction, and implementation of upgrades to existing and/or new facilities, utilities, and equipment.
Manage projects such as the design and installation of new or upgraded manufacturing lines and utility systems.
Manage the startup of new processes and technologies such as lyophilization, clean in place (CIP) / sterilize in place (SIP), water systems, waste systems, and utility systems.
Manage the design and construction of new and renovated facilities.
Manage departmental and capital budgets.
Manage day to day engineering support functions such as project development and drawing updates/requests.
Assist maintenance and operations in problem solving and process improvements.
Maintain cGMP, OSHA, and DEC compliance through implementation and adherence to SOP’s and governmental regulations.
Initiate, author, review, and approve change control, specifications, risk assessments, work orders, standard operating procedures (SOPs), capital project approvals (CPAs), purchase requisitions/orders, factory/site acceptance tests (FAT/SAT), corrective actions, and associated interim/final reports and other paperwork in compliance with Company policy.
Manage the preparation and approval of validation protocols for new and upgraded equipment, facilities, and utilities.
Review final documentation packages for all major systems at the plant including, but not limited to utility systems, filling operations, packaging operations, dry heat sterilization/depyrogenation, steam sterilizers and process washers.
Participate in and resolve audit and regulatory deficiencies.
Serve as reviewer and approver for deviation investigations
Hire, develop, organize and lead staff.
Establish and implement appropriate engineering staff training requirements.

BS in an Engineering/technical discipline required, masters preferred. MBA a plus.
Minimum of 5 years of experience in an engineering and/or cGMP manufacturing environment, preferably a pharmaceutical environment
Knowledge of all aspects of manufacturing processes, automation and controls such as PLCs and HMIs, machine design and layout, utilities and piping including compressed air and gasses, steam and water systems, HVAC, fire protection, project management, Autocad, construction, drawing standards including the ability to read and decipher drawings including process and instrumentation (P&ID), and general supervision.

Please visit to apply

Sandeep Singh Dhillon
Validation – Compliance Specialist (Pharmaceutical) at Eclaro –
Pharma Job Portal

About the Job
Validation – Compliance Specialist

Work for a global healthcare leader. Eclaro is looking for a Compliance Specialist for our client located in New Brunswick, NJ.

Eclaro’s client is world-renowned for providing innovative healthcare solutions and for its commitment to improving the health and well-being of people from all walks of life. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Managing and coordinating activities related to cGMP Enterprise Electronic Systems. Duties include leading, developing, and maintaining compliance activities across IT Enterprise Services supported regulated GPS applications. Responsible for developing policies and procedures and coordinating all activities relevant between the Quality departments, IT validation and information technology in relation to implementation, maintenance and change control of computerized systems.

A key focus of this role will be to provide quality/compliance oversight to all computer system validation related activities across the GPS enterprise. The manager will guide the staff to ensure a comprehensive System Development Lifecycle Methodology in alignment with GAMP 5 requirements..

This role will also provide support services and governance to all supporting IT areas (GPS corporate and sites) to ensure global alignment to the computer compliance, global validation and change control standards.
Responsibilities also include providing support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned.

Other responsibilities:
Evaluates and administers consultation on computer validation issues related to Quality related computer systems; works closely with Information Technology and Quality Operations on these related issues.
Ensures enterprise level metrics and tracking for Corporate Computer related CAPAs are maintained and reported appropriately.
Develops and implements policies and procedures related to Quality related system compliance activities related to Risk assessments, validation and the overall maintenance of system state of control.
Ensures compliance with all Company policies and procedures, including safety rules and regulations.
Partners with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
Performs related duties as assigned.
21CFR11/ EU GMP Annex 11 and GAMP 5 standards
Data Integrity Guidance
Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements
Project management practices and techniques
Software development life cycle
Computer hardware and software applications including Quality related computer systems, MS Office and MS Project
Principles and practices of computer compliance, validation and qualification
Knowledge of automated testing practices and tools a plus
External and internal inspections
Skilled in:
Stakeholder management in a cross-functional organization
Reviewing user, functional and design specifications.
Reviewing and executing protocols and test scripts
Sampling, testing and measuring techniques.
Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
Selecting, training, supervising and evaluating departmental personnel
Managing multiple projects, duties and tasks,
Communicating clearly and concisely, both orally and in writing.
Establishing and maintaining effective working relationships with those contacted in the course of work.
Bachelor’s degree in a related field from an accredited college or university, with a minimum of 5 years of related experience

If hired, you will enjoy the following Eclaro Benefits:
401k Retirement Savings Plan administered by Merrill Lynch
Commuter Check Pretax Commuter Benefits
Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

Interested in applying?
Contact Cheryl Buot and/or send your resume to Cheryl.Buot@eclaro.comHelp now.

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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Sandeep Singh Dhillon
Quality Engineer – Investigations at Nexgen Pharma, Inc Irvine, CA 92614
Pharma Job Portal

About the Job
NexGen Pharma, Inc., a leader in quality pharmaceutical manufacturing and nutritional products for over 80 years. We provide a work environment that is fast-paced and entrepreneurial where our human capital is valued as the number one asset. We create success through a goal-oriented and goal-achievement atmosphere, surrounded by a committed staff and management team.


Manage the problem analysis and corrective action/preventative action (CAPA) quality elements

Investigate and resolve non-conformances and deviations in a timely manner

Collate information, write justifications and manage the Continuous Quality Improvements program

Technical resource within the plant for problem solving, Non Conformances /CAPA system

Lead, perform and analyze the tracking and trending of Quality Events, Non Conformances, investigations and CAPA(s)

Manage the site Quality Event escalation program associated with lot or system disposition issues and Hold Events

Manage the day to day activities for the timely initiation, tracking and closure of Non Conformance and CAPA(s)

Perform statistical analysis of Quality Events data required for investigations

Assist manufacturing and other departments in identifying root cause and implementing effective corrective actions for those circumstances where quality standards are not met.

Train new personnel on the Investigations and CAPA system

Complete complaint investigations as requested and per timelines provided

Serve as back-up to Batch Records Auditor including, but not limited to identifying all lot non-conformances

Provide management periodic updates of Deviations and CAPA(s)

Perform other related duties as assigned


Bachelor’s Degree, preferably in Science, Engineering, Math, statistics, or equivalent combination of education and experience

12+ years of non-conformance investigation experience

12+ years of experience in GLP or GMP environment

Able to interpret GMPs and other government regulations

Able to coach and train new personnel on the Investigations and CAPA system

Knowledge of manufacturing/processing techniques, laboratory procedures, Root Cause Analysis and statistical applications is preferred

Must have strong written and verbal communication skills

ASQ, black Belt or Green Belt certifications is a plus

Must demonstrate initiative, innovation and sound analytical problem solving skills.

Able to build rapport with coworkers and partner with other departments

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Sandeep Singh Dhillon
Quality Engineer – Root Cause Analysis/Medical Device/Investigation from Randstad Engineering
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This Job is located in Marion, NC -> United States

About the Job

Global medical device manufacturer has an immediate need in Marion NC for a Quality Associate III- Investigation Owner. This is a perm position and offers relocation assistance for the right candidate. The deviation owner leads the investigation of deviations that occur in operations and is responsible for authoring the investigation summary report. Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause and corrective and preventive actions. Interacts will all levels of staff and provides status updates as well as present the strategy for closure of deviations. Manage several investigations at a time.

Responsibilities for the Quality Engineer

Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures. Determine appropriate preventive actions to avoid reoccurrence of the deviation
Conduct personnel interviews to determine root cause of the deviation
Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate
Set up and run meetings with cross functional teams
Close deviations in a timely manner to meet business and compliance needs
Work with Subject Matter Experts and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective and preventive actions, complete trending analysis, and recommend product disposition
Present and defend investigations during regulatory inspections, as required
Requirements for the Quality Engineer

Bachelor’s degree in science or engineering
2-3 years of experience in root cause evaluation, interpreting regulations and quality systems within the medical device or pharmaceutical indsutry
5-8 years of experience in Manufacturing Operations and or Quality, or related field in the medical products industry
Must have a thorough understanding of pharmaceutical manufacturing process and equipment, preferably parenteral solutions, and current Good Manufacturing Practices (cGMPs)
Must have good analysis, troubleshooting, and investigation skills
Must be able to put complex thoughts and issues into writing in such a manner than an educated, but uninformed reader can understand and make decisions based on the written investigation report

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Sandeep Singh Dhillon
R&D Reporting Specialist –
Pharma Job Portal

Job Summary
Job Status/Type: Full Time Temporary/Contract/Project
Job Category: IT/Software Development
Occupation: General/Other: IT/Software Development
Industry: Staffing/Employment Agencies
Career Level: Experienced (Non-Manager)Reference Code: 102914

Looking for a data orientated candidate that is comfortable with ambiguity and forging ahead to find solutions and drive process.


• Contribute to the set-up, maintenance and reporting of data in the HCP Payment and Spend System (HCP PASS). Monitor performance of reporting system and provide recommendations for process or system improvements where appropriate.

• Review contracts and payments to determine what must be reported against a healthcare provider (HCP) and/or teaching institution to comply with internal and government reporting purposes.

• Gather information to ensure that all payment and transfers of value information is captured and coded and provide guidance to influence appropriate decisions regarding all payment and in-kind reporting.

• Compile gathered information and perform data review cross checks to ensure information is accurate, complete and consistent. Identify missing, inaccurate, or incomplete data and liaise with functional areas to obtain updated data. Independently trouble shoot for missing data and documentation needed to complete required reporting. Key areas of collaboration include the following:

? Liaise with Clinical study team leads to gather details and documentation about reportable study supplies and equipment used in R&D clinical studies.

? Liaise with Compliance Operations to understand company reporting needs for R&D meetings. Work with R&D meeting owners to gather information about planned R&D meetings (e.g. investigator meetings, advisory board meetings). Review meeting request documentation for completeness (details about meeting attendees and venue) and coordinate compliance review.

Job Requirements

• Basic understanding of one or more of the following: clinical study costs, Sunshine Act requirements and reporting, contracts, finance, data management, databases, and compliance

• Experience working in the pharmaceutical industry, especially in research and development

• Knowledge of clinical research and drug development concepts and FDA GCP/ICH regulatory guidelines, and understands clinical terminology

• Intermediate-advanced skills with MS Excel (skilled in using pivot tables and vlookups)

• Bachelor’s degree with 6 years relevant work experience or 4 years relevant work experience with a Master’s degree. 2 years relevant experience required with a Doctorate.

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Sandeep Singh Dhillon
ID 1230 R&D Scientist – Pharma – injectables or semisolid exp
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ID 1230 R&D Scientist – Pharmaceuticals — injectables or semi-solid exp

Arlington Heights, IL

This role will provide technical expertise for process development to expand manufacturing processes and will aid pilot scale to commercial batches.


  • Conduct pilot scale batches
  • Support launch batches
  • Prepare protocols for verification batches
  • Assemble proper reports and prepare presentations


  • BS Degree, Masters preferred
  • 5+ years of industry experience
  • Experience using analytical equipment
  • Topical formulation experience
  • Aseptic and Semisolid experience

Other Details
Relocation Assistance: Yes
Type: Full time, direct hire
Benefits: Full
Travel: Occasionally
Visa Sponsorship: Yes

We are an equal opportunity staffing agency. Qualified applicants will be presented to employers without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status.*

(ms OR m.s OR master OR master’s OR masters OR phd OR ph.D OR doctor) AND (pharma OR pharmaceutical OR pharma* OR “medicinal drug” OR pharmacy OR pharmacists OR drug OR “health care” OR healthcare OR Biotech) AND (Sterile OR aseptic OR injectable OR semisolid OR semi-solids OR liquid OR QbD OR “topical dosage” OR “semi-solid dosage” OR “semi solid dosage” OR “Lyo Injectables” OR “Quality by Design” OR lyophilization) AND (suspensions OR development OR improvement OR validation OR cGMP OR ICH OR supac OR “ph meters” OR osmometer OR viscometer) AND (R&D OR “research & development” OR “research and development”)

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Sandeep Singh Dhillon
Experienced Project Manager (Full-Cycle Drug Development) – RTP Pharma/Top $$ at Frankel Staffing Partners Durham, NC 27709 (
Pharma Job Portal

About the Job
Our client, an RTP-based pharmaceutical firm undergoing tremendous change and expansion, is actively recruiting for a skilled and knowledgeable Project Manager for key role on its growing R&D team. This is a dynamic and challenging setting. Seek a very sharp, versatile, take-charge professional who can effectively pull together the resources of the entire drug development process and help drive them towards a successful conclusion.

This company is developing a highly anticipated portfolio of products in the dermatological space.

This PM will be responsible for developing and managing the project plan and driving execution across multiple cross-functional areas including manufacturing, clinical, regulatory, quality, and commercial.

Seek candidate who will ensure smart project team planning and operational execution — from early development to regulatory approval and beyond.

Independent consultants and CROs are utilized for certain functions. See quality candidate with proven ability to lead in an outsourced model.

Specific responsibilities will include:

Ø Develop detailed project plans and organize activities and milestones to ensure projects are delivered within budget, in scope, and on time.
Ø Establish and implement project management processes and methodologies for product development activities including project planning, resource planning, project scheduling and leading teams to accomplish project goals.
Ø Facilitate information flow between departments and senior management, ensuring all stakeholders are clear on timelines, expectations and deliverables
Ø Anticipate project/program risks and develop mitigation strategies/plans for more complex projects/programs
Ø Create and utilize appropriate planning tools such as decision support models, Gantt charts, and project timelines to ensure accountability throughout the organization. Ensure that responsibilities are understood, risks are identified, progress is measured and plans are updated and adapted as necessary
Ø Identify and escalate project obstacles and risks and make recommendation to project team and management to mitigate, troubleshoot, and resolve issues
Ø Serves as a project management advocate and mentor

Selected candidate will offer a related degree and 7+ years of increasingly responsible and impactful roles in drug development, including an impressive track record in project management leadership.

Broad understanding of NDA requirements assumed and important. PMP certification, a plus. MS Project expertise, a must.

This is a dynamic, empowered, collaborative and mission-driven setting. In addition to technical requirements noted above, we seek a smart, insightful, self-directed and extremely competent professional who can gain the respect and cooperation of colleagues and partners in order to achieve shared success. Superb communication skills and savvy will be essential.

This is an immediate need and a critical need. Client will pay top dollar to attract and retain a star.

Qualified candidates should forward Word resume for prompt consideration. Thank you for your time.

Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at

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Sandeep Singh Dhillon
Compliance Specialist – Pharmaceutical (Philadelphia, US)
Pharma Job Portal

Job Description

Permanent position for a Compliance Specialist to conduct quality system audits ensuring compliance with SOPs and cGMPs. Perform Out of Specification (OOS) and nonconformance investigations in the analytical chemistry and manufacturing departments.
Assist QA department by maintaining and improving cGMP quality Systems.
Conduct Internal/external audits and prepare reports of analytical laboratory and manufacturing facilities.
Collaborate with all departments to develop and implement Corrective and Preventive Action (CAPA) plans. Observe and report effectiveness of CAPA plans.
Conduct Root Cause Analysis investigations and impact/risk assessments in response to deviations non-conforming events and audit observations
Prepare investigative test plans for non-conforming events.
Generate monthly metrics and quarterly trend reports for OOS investigation, non-conforming events and CAPAs.
Review change controls for impact and risk assessment

BS in Science related discipline
Minimum 3 years of experience in pharmaceutical manufacturing or related industry.
Experience conducting quality audits in an analytical laboratory or manufacturing environment.
Knowledge of cGMPs and FDA regulations related to analytical and pharmaceutical manufacturing practices.
Team player with excellent communication and interpersonal skills.
Experience with MS office software, including Word, Excel, Outlook.

Contact: Jessalyn Cotter

Please send all inquiries to [LINK:]

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