Stratus Therapeutics

Supervisor, Manufacturing

Watertown, MA
Full Time
Manufacturing
Experienced
Position Title: Supervisor, Manufacturing
Reports to: Director, Manufacturing
Status: Regular, Full-Time, Exempt
Location: Watertown, MA (Onsite)

Company Summary: Stratus Therapeutics is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells.  We have breakthrough potential to provide patients with rapid and broad access to HLA-compatible transgene-free blood stem cell therapies.

Stratus Therapeutics is committed to advancing science and enhancing the health and well-being of patients. This commitment, along with an exciting team culture, drives our efforts to develop an off the shelf stem cell therapeutic platform.

Position Summary: The Manufacturing Supervisor will be responsible for supervising a team of cell therapy Manufacturing Associates and Specialists in a fast-paced, results driven, start-up environment. This individual will be responsible for specific units of operation during production campaigns, including scheduling, trouble shooting and escalating problems, and ensuring that documentation and process execution are GMP compliant. The Manufacturing Supervisor will work collaboratively across departments, including Quality Control, Quality Assurance, Process Development, Supply Chain, and Operations. They will develop their team of direct reports, including setting annual performance goals and objectives, providing opportunities for career growth, and coaching and training new hires. The Manufacturing Supervisor will play a vital role in supporting key business activities at Stratus Therapeutics as we advance to the clinic.

Specific responsibilities include, but are not limited to:
  • Plan and coordinate manufacturing activities in preparation for and during manufacturing campaigns
  • Train, coach, and mentor direct reports on manufacturing functions
  • Work with your team to establish annual individual goals and objectives and assess performance against these goals and objectives
  • Train new team members to ensure that they can execute GMP Manufacturing processes successfully
  • Escalate and troubleshoot process problems as necessary
  • Work with manufacturing personnel to identify opportunities for operational process improvements
  • Ensure team members are trained to author/revise batch records, SOPs, deviation investigations, and CAPAs
  • Review batch records, SOPs, deviations investigations, and CAPAs
  • Collaborate with Process Development, Quality Assurance, Quality Control, and Supply Chain as needed to ensure compliance with GMP regulations and data integrity
  • May perform as subject-matter expert (SME) during manufacturing processes
  • Participates in, and may facilitate cross-functional meetings and discussions to ensure interdepartmental alignment
  • Support Process Development activities, including writing and executing study plans

Qualifications include:
  • Associate’s degree is required (in a science-related discipline preferred) and a Bachelor’s degree is preferred
  • 1+ year of Supervisory experience working on the manufacturing of a cell-based therapeutic product is preferred
  • 3+ years of Cell Therapy GMP manufacturing or equivalent experience is required
  • Able to be a hands-on leader, managing a dynamic workload while multi-tasking and performing effectively under tight deadlines
  • Strong interpersonal skills & attention to detail are required
  • Deep commitment to teamwork, collaboration, and professionalism
  • Proficiency in working with MS Office Suite is required, Quality and/or Document Management System experience is preferred
  • The ability to lift 30 lbs. is required
  • Must be able to laugh and contribute to a positive work culture


AAP/EEO Statement
Stratus Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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