Manager/Senior Manager, Manufacturing

Company Summary:

Tessera Therapeutics is pioneering Gene Writing™— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.

Position Summary:

The Manufacturing Manager will be responsible for implementing and executing manufacturing processes in Tessera’s new Boynton Yards clinical manufacturing facility located in Somerville, MA.  We are searching for a driven, enthusiastic, and self-motivated individual who can support facility startup activities and provide guidance and oversight to production processes, ensuring on time and compliant delivery of clinical materials. This individual will report directly to the Director of Technical Operations and will join a dynamic, rapidly growing, and highly collaborative team.

Key Responsibilities:

• Support CQV activities for facility and equipment including document review and on-site execution in partnership with validation, quality, and engineering resources
• Perform manufacturing operations in a cleanroom environment using aseptic processing techniques
• Provide oversight to the production process ensuring material is made in a safe and compliant manner in a new facility to achieve demand targets
• Author operational documentation including SOPs, Batch Records, Logbooks, Deviations, CAPAs, and Change Controls
• Schedule and coordinate day-to-day activities and ensure conformance to the schedule and planned manufacturing batches
• Ensure efficient, safe, and compliant operations are implemented and maintained
• Engage cross functionally with CMC team members and Quality functions
• Provide ongoing manufacturing process improvements to improve process efficiency and robustness
• Hire, supervise, train, and develop a team of associates

Basic Qualifications:

• BS in Engineering, Life Science Discipline or related technical field
• 5+ years of hands-on experience in cGMP operational or supporting role
• Hands on experience in a cleanroom environment
• Detailed knowledge of cGMPs and good documentation practices
• Demonstrated ability to learn and apply new disciplines
• History of working independently and working collaboratively in a fast-paced environment
• Strong attention to detail, a good problem solver, and results oriented

Preferred Qualifications:

• • Experience leading and/or supporting facility and equipment startup activities
  • Experience with single use systems and technologies
  • Knowledge of FDA guidance for gene therapy manufacturing
  • Experience building and leading a team of associates

 

More About Flagship Pioneering

Flagship Pioneering has conceived of and created companies such as Moderna Therapeutics (NASDAQ: MRNA), Editas Medicine (NASDAQ: EDIT), Omega Therapeutics (NASDAQ: OMGA), Seres Therapeutics (NASDAQ: MCRB), and Indigo Agriculture. Since its launch in 2000, Flagship has applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures. In 2021, Flagship Pioneering was ranked 12th globally on Fortune’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies.

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

 

Recruitment & Staffing Agencies:  Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates.  The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team.   Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.