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Oct
13
Sandeep Singh Dhillon
Quality Engineer – Investigations at Nexgen Pharma, Inc Irvine, CA 92614
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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.

RESPONSIBILITIES:

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

QUALIFICATIONS:

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

Apply at http://job-openings.monster.com/v2/job/apply?jobId=189083055

Sep
18
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

Apply at http://engineers.randstadusa.com/think.nsf/b2_apply1?openform&jt=Quality%20Engineer&ParentUNID=CC1F769477EDCE7A85258167006D17F2&frm=mon_kw&mdm=job%2Bpost&nme=Job%2BBoards&frm1=mon_kw

Sep
18
Sandeep Singh Dhillon
R&D Reporting Specialist – Monster.com
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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.

Responsibilities:

• 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.
Category:Non-ITcode:new

Job Requirements
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.

Apply at http://apps.collabera.com/jobs/Post_Details.aspx?qsPostId=102914&src=col_mon

Sep
6
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

Location
Arlington Heights, IL

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

Duties

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

Requirements

  • 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”)

Apply at http://jobs.cameroncraig.com/JobSeeker/Profile.aspx?jobid=02498614

Sep
6
Sandeep Singh Dhillon
Experienced Project Manager (Full-Cycle Drug Development) – RTP Pharma/Top $$ at Frankel Staffing Partners Durham, NC 27709 (Monster.com)
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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 www.frankelstaffing.com.

Apply here at http://job-openings.monster.com/v2/job/apply?jobId=187456593

Aug
24
Sandeep Singh Dhillon
Compliance Specialist – Pharmaceutical (Philadelphia, US)
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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: mailto:Jessalyn.Cotter@TerkoTech.com] Jessalyn.Cotter@TerkoTech.com

Apply here at http://jobs.terkotech.com/jobdetails//jobdetails/compliance-specialist-pharmaceutical-philadelphia-pa-us-19154/2006
Aug
10
Sandeep Singh Dhillon
Senior Scientist, Organic Synthesis – Pacific Biosciences (Glassdoor US)
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Senior Scientist, Organic Synthesis

Location: Menlo Park, CA

Pacific Biosciences is looking for a Scientist/Senior Scientist, Organic Synthesis to manufacture our fluorescent compounds. In this position the person will work on process optimization, scale-up and manufacturing of the targeted compounds. The candidate will need to be capable of performing activities required while developing and optimizing the synthesis and purification processes associated with our dye labeled compounds for yield, performance and quality. This position requires in-depth relevant experience in organic synthesis with the capability to support and maintain robust, reliable and accurate processes in manufacturing.

This person will interface with a broad range of functional groups, and needs to have good communication skills. As a developer, this person will be responsible for correlation of processes and physical specifications to system performance metrics.

Responsibilities:
  • Route selection for the most efficient way to synthesize the required compounds.
  • Extensive lab work designing and executing experiments, and analyzing resultant data.
  • Process optimization and scale-up.
  • Establishing the right set of the documentation, related to products production.
  • Collecting and analyzing the analytical data.
Position Requirements:
  • Ph.D. in Organic Chemistry with 3+ years of relevant experience in Pharmaceutical industry.
  • Extensive experience in organic synthesis, process optimization and scale-up.
  • Experience in fluorescent dyes and nucleotide synthesis is highly desirable.
  • Strong knowledge in purification methods and analytical techniques.
  • Knowledge and work experience in GMP environment is a plus.
  • Strong communication skills, team work and initiative.
  • Appreciation of process quality and specifications as a requirement for manufacturing.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.
Aug
10
Sandeep Singh Dhillon
Scientist, Small Molecule Pharmaceutics, Genentech Research – San Francisco (Glassdoor US)
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Job Description

Scientist, Small Molecule Pharmaceutics, Genentech Research
South San Francisco, California
United States

Job ID: 00453071

The Position

We are seeking a Scientist to support drug discovery in the Department of Small Molecule Pharmaceutics at Genentech. The primary responsibilities for this role extend from formulation and pharmaceutics support from early stage research to late stage research, IND-enabling safety studies, and informing development strategy for clinical formulation. This person will primarily be responsible for pharmaceutical profiling and drug delivery approaches during preclinical assessment of novel small molecule therapeutics for unmet medical needs.

The successful candidate is expected to:
Drive scientific and technical innovation collaboratively with other members of Discovery teams and within Small Molecule Pharmaceutical Sciences.
Focus on selection, profiling and advancing small molecule clinical candidates in a scientifically rigorous, phase-appropriate manner
Develop and execute pre-formulation and preclinical formulation strategies based on strong scientific rationale and pharmaceutical/biopharmaceutical properties of molecules for one or more projects
Based on preclinical knowledge, identify potential risks during clinical formulation development.
Leverage preclinical knowledge, participate in key decisions such as physical form selection and clinical formulation design
Have a proven track record of publication in high quality scientific journals
Participate and thrive in an interactive, collaborative, team-oriented culture, interfacing with discovery and early development functions
Who You Are

A Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering or related fields with 3-8 years’ experience in the pharmaceutical industry. Knowledge and expertise in the interplay between molecular physicochemical properties, absorption processes, and pharmacokinetic/pharmacodynamic (PK/PD) relationships with formulation modality is required. Experience in working within the drug discovery space is highly desired. Additionally, experience in alternative therapeutic modalities (such as peptides, etc.) and drug delivery technologies (such as inhalation, ocular, topical, etc.) is highly valued.

The successful candidate must have excellent communication skills, interpersonal skills,
and problem-solving skills, as well as demonstrate the ability to plan, design, implement and analyze laboratory experiments to advance projects and guide formulation selection and development.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

Apply at https://www.gene.com/careers/detail/00453071/Scientist-Small-Molecule-Pharmaceutics-Genentech-Research?src=SNS-15161

Jul
28
Sandeep Singh Dhillon
Validation Engineer – BioPharm at Mangan Inc Cambridge, MA 02238 – Monster.com
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Company Description
Mangan Biopharm is a subsidiary division of Mangan Inc. and is a full service Engineering and Life Science Quality and Compliance Company. Mangan has over 25 years of experience in Engineering, Procurement and Construction with 15+ years of experience in Lifesciences Engineering and Compliance Consulting. We are customer-centric and fully committed to our clients needs and as a result, most of our business is repeat business.

Job Description

Position Summary:

The Validation Engineer is responsible for execution of validation projects for equipment, facilities, and utilities in a pharmaceutical manufacturing, packaging, or support environment. The candidate must be able to work independently, but be able to coordinate execution efforts with operations, manufacturing, facilities, laboratories, development, materials management and quality assurance personnel. This role will play an integral part in overall project success.

Duties:

Validation Engineer I ( 2 – 5 years of Experience/Salary range $60 to $80k)

 Reviews validation packets for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. Compares results against acceptance criteria and bring exceptions and deviations to management’s attention

 Maintains appropriate validation documentation and files in accordance with regulatory requirements and internal procedures

 Effectively apply validation methodology and standards

 Support, investigate and troubleshoot problems and determine solutions

 Provide technical assistance during investigations of process /equipment / cleaning / validation issues. Generate and resolve validation deviations / protocol discrepancies

Validation Engineer II ( 5 – 9 years of Experience/Salary range $80 to $100k)

 Analyze validation data, prepare summary reports and provide recommendations for improvement in manufacturing process and equipment

 Develop training packages, JSAs and writing Best Known Methods (BKM) for Validation

 Serve as a dependable liaison between validation and manufacturing

 Identify, respond to and monitor potential project risks and determine possible contingency plans for risk mitigation

 Reviews technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, flow diagrams as they relate to validation principles and regulatory compliance issues

Qualifications:

 Bachelor’s degree in engineering, science or related field

 Excellent organization and time management skills

 Good understanding of cGMP validation requirements / guidelines and current industry practices

 Results-oriented, able to make decisions, and able to prioritize validation project and client needs

 Strong teamwork and collaboration

 Must have excellent interpersonal, technical writing and communication skills

 Proficient in use of MS Office software suite

 Ability to work occasional off shift and/or weekends to accommodate schedules and/or project timelines

Apply at http://job-openings.monster.com/Validation-Engineer-BioPharm-Cambridge-MA-US-Mangan-Inc/11/186239493?JDNJobDocument.JobID=132549024&AdID=28361036&ImpressionGuid=fdaae5cd-6b40-2429-c1c6-3566f228ad51&AffiliateGuid=63315516-d696-4397-af9e-806bf6170167&CampaignID=240301&Premium=0&RendererID=2146&code=-1&unit=-1&stracking=&WT.mc_n=JDN000003

Jul
28
Sandeep Singh Dhillon
Pharmaceutical Formulation Development Advisor at UPM Pharmaceuticals
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About the Job

Pharmaceutical Formulation Development Advisor

UPM Pharmaceuticals, Inc., (upm-inc.com) a rapidly growing contract drug development and manufacturing company for the pharmaceutical industry, located in Bristol, Tennessee, is seeking two senior advisors/guides for pharmaceutical formulation development.

Essential Duties and Responsibilities: This role requires experienced formulation and process development scientists with project leadership experience in development of pharmaceutical solid oral dosage form products and manufacturing processes. Will provide science & technology guidance in support of client projects in various product development and manufacturing activities within time and budget constraints. Guidance will be provided to all levels within R&D, Manufacturing, Business Development, Quality, and Executive Management. Major activities include: contract proposal review; business development support; technical guidance for project leaders and participation in design of formulations and manufacturing processes; evaluation & implementation of new technology & equipment; attend team meetings; review documents; answer technical questions and participate in discussions; presence on mfg floor or lab during critical operations; write technical reports; advise on procedural, document, and batch record questions; advise registration and validation activities; and many other lesser activities.

Qualifications:

Pharmaceutical formulation development experience is required. Preference for CDMO (contract development and manufacturing operation) experience with solid oral dosage forms and a PhD, but not required.

Academic study of industrial & physical pharmacy, pharmaceutical chemistry, chemical engineering, chemistry, or biochemistry; skill in the science & art of pharmaceutical product development; experience & knowledge of pre-formulation, formulation development, clinical manufacturing, analytical testing, quality control & assurance, cGMP, & GLP; knowledge of programs like Outlook, Word, Excel, Access, TrackWise, and Documentum; knowledge of contract development, concept product development, clinical phase 1, 2, and 3, bio batch, registration, and validation; experienced with IND/NDA/ANDA, QBD, CPP, DOE, and RLD activities; detail oriented, a self-starter, excellent organization & communication skills; ability to handle multiple tasks involving various departments in a fast-paced environment; effective interpersonal skills; ability to read, analyze, interpret, & write scientific documents/reports; the will & ability to achieve success.

Apply at

http://job-openings.monster.com/Pharmaceutical-Formulation-Development-Advisor-Bristol-TN-US-UPM-Pharmaceuticals/11/185132690