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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 an Engineer IV, Downstream Pilot Plant
in our Lexington, 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:
Sitting within R&D, Pilot Plant is at the interface between lab-scale studies and full-scale GMP manufacturing and operates at the 50-500L bioreactor scale. The individual in this role will be a key member leading large scale downstream operations and development experiments, including chromatography, ultrafiltration/diafiltration, and/or depth/sterile/nano-filtration of non-GMP batches to support program timelines. The individual will independently execute both routine and complex operations. Additionally, this position plans unit operations/experiments and drafts support documentation (SOPs, batch records, and/or reports). They will collaborate within our multi-disciplinary environment including the upstream/downstream pilot team, process development, manufacturing, and manufacturing sciences teams. They will possess excellent problem-solving abilities and hold strong coaching and supervisory skills. 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.
ACCOUNTABILITIES:
60% of the time: Lead/Perform non-GMP purification campaigns (pilot scale) to support new product development, material supply needs and demonstration runs for multiple programs spanning all phases of biopharmaceutical development. Lead project team to support the transfer of all information including long lead items, batch record development, sample plan building, ordering and vendor management, and on-floor support schedules. Record, trend, and interpret data independently, and organize and present issues and results at departmental and project meetings. Identify complex technical issues and implement solutions under supervision. 25% of the time: Actively participate and interact with process development groups to identify and troubleshoot problems, support large scale studies, and support project goals. Design and develop pilot scale operating procedures and records suitable for use in the production of non-GMP material. Author documents such as reports, protocols, and internal presentations that may require substantial edits. Assist senior personnel with publications, external abstracts, and presentations, as needed. 10% of the time: Evaluate and implement novel large scale technologies that meet a generic platform across multiple processes. 5% of the time: Mentor junior members of team in developing required skillsets.
EDUCATION, EXPERIENCE AND SKILLS:
Associate’s degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 7+ years relevant industry experience Bachelor’s degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 5+ years relevant industry experience Master’s degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience Previous Process Development, Manufacturing Sciences, or Manufacturing hands-on experience working with bioreactors/fermenters from bench top to production scale, including process monitoring and process control.
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.
LINE FUNCTION SPECIFIC QUALIFICATIONS:
Biologics – Pilot Plant – non-GMP:
The candidate should possess knowledge of, experience in, and troubleshooting of activities routinely performed in downstream processing (e.g., traditional and continuous chromatography, UF/DF, filtration, column packing, and buffer preparation). Practical experience around scale-up, technology transfer, and manufacturing support of large scale GMP operations is desired. Knowledge of upstream processing is a plus.
The candidate must demonstrate excellent written and verbal communication skills and have an ability to independently operate pilot scale equipment, interpret data and maintain an organized lab area. In addition, the individual should be a self-starter and be able to communicate effectively with external and internal stakeholders. Candidate must have excellent problem-solving skills and be able to work in a fast-paced team environment.
The candidate should display excellent leadership skills, documentation skills and troubleshooting abilities. The candidate will document development activities accurately in research notebooks and paper/electronic batch records as per corporate guidelines and provide concise reports and updates to management as required.
The candidate will be expected to effectively complete day to day operations while managing data and communicating with external stakeholders. The candidate will be expected to work closely with PD operations management, deliver detailed updates, and display sense of urgency while completing critical tasks. The candidate will be expected to provide solutions to help troubleshoot pilot scale operations and central service-related issues.
This role will occasionally require adjusted work schedules to meet operational demands.
TRAVEL REQUIREMENTS:
Occasional travel may be required (domestically and internationally) for conferences, seminars, and project specific needs (approximately 5% travel).
BENEFITS:
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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No Phone Calls or Recruiters Please.
This job posting excludes CO applicants.
Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.
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.
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.
Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time