Lead Staff Engineer for our Viral Vector Lab (VVL) at Takeda Development Center Americas, Inc. in Boston, Massachusetts

Job Description:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Lead Staff Engineer for our Viral Vector Lab (VVL) in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

The successful candidate will be a key, lead member within a group responsible for owning and performing non-GMP Pilot upstream cell culture operations within a viral vector lab supporting both cell and gene therapy teams. This includes vial thaw, expansion, and production of both adherent flask/stack operation as well as suspension cultures, harvest, and filtration of batches to support development and clinical timelines. They will collaborate within the upstream and downstream pilot team as well as with the process development and in-process analytics teams. This individual will lead the non-GMP upstream efforts and is responsible for independently preparing and executing routine and complex experiments and unit operations. Additionally, this position leads in planning unit operations and experiments under limited supervision and drafting support documentation (SOPs, batch records, and/or reports). They will seamlessly collaborate within the framework of cross-functional process development teams including engineers and manufacturing teams. They will possess excellent problem-solving abilities, hold strong coaching and supervisory skills, and communicate well within our multi-disciplinary environment including process development, manufacturing, in-process analytics, and manufacturing technical support teams. They will apply knowledge from various technical areas, industry practices and standards and provide quality and productive output that is consistently timely, reliable and reproducible. The candidate must be customer focused, results oriented, science driven, and have high attention to detail.

POSITION ACCOUNTABILITIES:

• Lead all technical operations within the Viral Vector Lab (VVL) for the upstream unit operations, both adherent and suspension, as well as process monitoring and data acquisition.




• Create material supply campaign plans and leads coordination efforts with Cell and Gene therapy teams to meet timeline and quantity demands.




• Own responsibility for aspects of tech transfer from non-GMP Pilot team of cell culture process for biologics production into cGMP manufacturing space




• Work with departmental and/or cross functional peers to execute on assignments, under limited supervision




• Document data accurately in laboratory notebooks and batch records completely as per established company guidelines/SOPs. Writes documents such as reports, protocols and internal presentations that may require substantial edits




• Help lead studies and technology evaluations that lead to IP, publications, external abstracts and presentations at industry events and conferences




• Organize and present issues and results at departmental and project meetings.




• Contribute significantly to project work which may include multiple projects within functional area




• Interpret data independently, and contributes to technical reports




• Identify complex technical issues, and implements solutions under limited supervision




• Contribute to the design of new applications/experiments/unit operations in consultation with manager.




• Support technology transfer through writing and consolidating technical documents.




• Coordinates within department as well as cross functionally with peers on projects

EDUCATION, EXPERIENCE AND SKILLS:

Education Requirements

Required:

• Associates degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 10+ years relevant industry experience




• Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 7+ years relevant industry experience




• Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3-5 years relevant industry experience




• Previous experience working in GMP manufacturing setting desired

Knowledge and Skills:

• Analytical and Problem-Solving Skills -Able to troubleshoot critical issues or problems and resolve routine issues using appropriate information. Stands accountable and consistently follows through on work assignments and personal objectives to deliver high quality results despite obstacles.

• Teamwork -- Ability to work within department groups/team.




• Communication Skills - Expresses one’s self clearly and concisely within function; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor




• Organization – Exercises good time management skills. Effectively manages multiple priorities and outcomes of critical tasks.




• Technical - Proficient in use of applicable lab equipment and operations

PHYSICAL DEMANDS

• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.




• Ability to lift, pull or push equipment requiring up to 25-75 lbs of force.




• Ability to stand for 6 hours in a suite.




• Ability to climb ladders and work platforms.




• Stooping or bending to check or trouble-shoot equipment operations.

LINE FUNCTION SPECIFIC QUALIFICATIONS

Biologics – Pilot Plant – non-GMP & cGMP suite:

• Extensive experience with cell culture is required with purification experience also desired, as this role will support both upstream and downstream operations. Experience with cell culture and aseptic techniques; Experience with laboratory equipment that supports cell culture, such as bioreactors and/or adherent culture stacks, metabolite analyzers, shake flasks, cell culture plates; Experience with using automation preferred; Experience with electronic batch record system preferred; Good understanding of chromatographic and other protein separation principles; Familiarity with use of bioseparation equipment and standard analytical assays.




• May be required to adjust work schedule to meet operational demands.




• Work includes a combination of cell culture (seed train/expansion/production bioreactor), harvest operations (filtrations or centrifugation), buffer planning and ordering, scheduling, large-scale column packing, sample forecasting and submission, metabolite or sample measurement, assisting with assembly and disassembly of process equipment, authoring batch records/SOPs or proposing document revisions, and execution of these records in both a cGMP and a non-GMP environment. The individual may contribute to the evaluation of novel, generic platform technologies that can be applied across multiple programs.

TRAVEL REQUIREMENTS

• May require approximately up to 0-5% travel

WHAT TAKEDA CAN OFFER YOU

• 401(k) with company match and Annual Retirement Contribution Plan




• Tuition reimbursement Company match of charitable contributions




• Health & Wellness programs including onsite flu shots and health screenings




• Generous time off for vacation and the option to purchase additional vacation days




• Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

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*This job posting excludes CO applicants*

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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