19 days old

Staff Engineer - Pilot Plant/Manufacturing

Millennium Pharmaceuticals, Inc.
Boston, MA 02109
  • Job Code
    R0030245

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Job Description

Are you looking for a patient-focused, innovative-driven company that will inspire you and support your career development? If so, be empowered to take charge of your future at Takeda. Join us as a Staff Engineer in our Cambridge, MA office to be a part of a team responsible for performing both GMP and non-GMP Pilot cell culture operations as well as limited downstream work, involving multiple filtration and/or chromatography techniques.

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 a wavering 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:

Staff Engineer will be a member within a group responsible for performing both GMP and non-GMP Pilot cell culture operations as well as limited downstream work, involving multiple filtration and/or chromatography techniques. This includes expansion and production adherent flask/stack operation, harvest, and purification of batches to support development and clinical timelines. Staff Engineer will collaborate within the upstream and downstream pilot team and with the process development teams.

Staff Engineer will help lead the GMP efforts and is responsible for independently executing routine and complex experiments and unit operations. Additionally, this position participates in planning unit operations/experiments under 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, quality, 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:

  • Owns responsibility for technical aspects of tech transfer from non-GMP Pilot team of cell culture and downstream process for biologics production into cGMP space

  • Leads the draft, review, and release of GMP SOPs and Batch Records for manufacturing processes.

  • Perform investigations into manufacturing deviations by use of EMS quality systems

  • Lead the implementation of CAPA in response to manufacturing excursion management

  • Participate in all aspects of GMP preparations and readiness including receipt of raw materials, equipment validation, tech transfer documentation

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

  • Documents 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. Assists senior personnel with publications, external abstracts and presentations, as needed.

  • Organizes and presents issues and results at departmental and project meetings.

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

  • Interprets data independently, and contributes to technical reports

  • Identifies complex technical issues, and implements solutions under supervision

  • Contributes to the design of new applications/experiments/unit operations in consultation with supervisor.

  • Supports 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 and Experience:

Required:

  • Associates degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience

  • Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience

  • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3-4 years relevant industry experience

  • Previous experience working in GMP manufacturing setting or Masters degree plus appropriate laboratory training

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 ones 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

LINE FUNCTION SPECIFIC QUALIFICATIONS

Biologics Pilot Plant non-GMP & cGMP suite:

  • 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.

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.

TRAVEL REQUIREMENTS:

  • The candidate may be asked to travel occasionally (domestically and internationally) for conferences, seminars, and project specific needs (approximately 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

No Phone Calls or Recruiters Please.

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-02-09 Expires: 2021-03-10
Sponsored by:
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Staff Engineer - Pilot Plant/Manufacturing

Millennium Pharmaceuticals, Inc.
Boston, MA 02109

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