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Jan
25
Sandeep Singh Dhillon
Sr. Manager, R&D at Germer International Billings, MT (Monster.com)
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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.

Education/Experience:

·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 https://job-openings.monster.com/Sr-Manager-R-D-Job-Billings-MT-US/11/192379224

Jan
25
Sandeep Singh Dhillon
Senior Analytical Development Scientist at Germer International Cedar Rapids, IA (Monster.com)
Pharma Job Portal
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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.

Please apply for the job at https://job-openings.monster.com/Senior-Analytical-Development-Scientist-Job-Cedar-Rapids-IA-US/11/192379211

Jan
25
Sandeep Singh Dhillon
Engineering Manager (Pharmaceutical Industry) at Germer International Buffalo, NY (Monster.com)
Pharma Job Portal
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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.

Responsibilities:

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.
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 https://job-openings.monster.com/Engineering-Manager-Pharmaceutical-Industry-Buffalo-NY-US-Germer-International/11/192647339 to apply