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Thermo Fisher Scientific Sr. Manager - Upstream Process Development in Princeton, New Jersey

Job Title: Sr. Manager - Upstream Process Development

Work Location: Princeton, NJ

Division: Pharma Services Group (PSG) Biologics

What Will You Do?

Leads a team of upstream scientists in process development including Supervisors and Managers for both cell line development and process development activities. Serves as the site lead for the upstream development group. Serves as a consultant to executive management. Plans and leads significant technical/scientific project activities to execute strategies and technical solutions that meet customer needs and expectations through broad expertise. Leads technical discussions with clients with a high level of technical proficiency.

Essential Functions:

Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; building relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

  • Leads high-level design of major experimental plans.

  • Conducts highly sophisticated analyses to support process development. Works with Process Development and Manufacture groups to trouble-shoot process challenges.

  • Sets guidelines for recording of results and reviews documentation by others.

  • Coordinates preparation of protocols, reports, and SOPs.

  • Maintains and ensures safe laboratory environment and work practices.

  • Reviews scientific literature and presents at appropriate scientific seminars and conferences.

How Will You Get There?

Education:

Bachelor's or Master's or PhD in biology, biochemistry, chemical engineering, or a related field.

Experience:

With Bachelor's degree, minimum of 15 years, Master's with a minimum of 13 years and Ph.D. with at least 10 years in a field related to pharmaceutical manufacturing, process development. Experience leading a team .

Equivalency :

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Advanced knowledge of principles, concepts, and practices in upstream process development, known as a SME in that subject area, and good knowledge of concepts of other relevant subject areas. Detailed knowledge of regulatory issues and the impacts on subject area. Strong knowledge of general cGLP procedures and those specific to process development. Knowledgable of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment. Demonstrated leadership skills. Excellent problem solving and critical thinking skills. Excellent writing, communication and presentation skills. Strong MS Excel, PowerPoint and Word skills. Microsoft Project skills preferred. Excellent organization and planning skills. Strong attention to detail. Ability to drive functional, technical and operational excellence. Ability to inspire and cultivate innovation, collaboration, clarity and team effectiveness. Ability to design complex studies based on the program objectives. Ability to analyze and summarize complex data. Ability to author reports, procedures, and other documents. Ability to function in a constantly evolving environment. Strong attention to detail and ability to adhere to standards procedures. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to make and communicate complex decisions. Apply complex mathematical concepts to physical problems in areas. Ability to guide manufacturing on the operation of all process steps. Ability to speak effectively before groups of customers and employees.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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