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:
This is a nine-month contract position with potential to extend/convert. The Senior Specialist, Quality Control will be responsible for documentation required for method qualification, implementation and operations. We are searching for a driven, enthusiastic and self-motivated individual who is comfortable multitasking and working independently on various aspects of the platform. This individual will join a dynamic, rapidly growing, and highly collaborative team.
The successful candidate will work both independently and as part of a collaborative team to ensure readiness of QC in-process, release and stability test methods used for Tessera drug substances and drug products.
Key Responsibilities:
- Manage method qualification timelines/planning and communicate project status cross-functionally
- Own method qualification protocols and reports for internally and externally performed QC methods used for drug substances and drug products
- Own SOP(s)/Forms required for QC method performance of drug substances and drug products
- Own stability study protocol/reports required to establish product expiry and manage logistics of stability study
- Own review of QC data including method qualifications, stability studies and GMP testing
- Support the establishment of Tessera’s QC critical reagent program
- Ability to perform lab work for method qualifications, stability studies and/or GMP testing is optional
Basic Qualifications:
- Bachelors degree, at minimum, in biology or related field with at least 4 years of industry experience is required.
- Previous experience in method development, qualification and/or validation of GMP methods
- Strong understanding of regulatory guidance for method validation and verifications including ICH, USP, FDA and EU
- Understanding of industry guidance for product stability and expiry date establishment (ICHQ1A)
- Previous laboratory experience with at least three of the following: molecular-based assays such as qPCR, ddPCR or NGS, analytical chemistry-based assays such as HPLC or LC-MS/MS, cellular-based or ligand-binding assays such as bioassays or ELISA
Preferred Qualifications:
- Previous experience includes Analytical Development or Quality Control roles supporting GMP testing/manufacturing (preferably internal) of cell therapy, gene therapy or gene editing products
- Experience in performance or technical oversight of compendia assay testing / product verification
- Skills that will help this candiate be successful include attention to detail as well as strong collaborative and organizational skills
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.
