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 Quality Control Analyst I/II will be responsible for documentation required for GMP method performance of molecular, plate-based and automated assays. 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. This position is a contract role through the end of 2023, with the possibility of extension/conversion and may leveled up based on years of experience.

Key Responsibilities:

• Perform molecular plate-based and automated-based assays as part of GMP in-process, release and stability testing of clinical drug substance and drug product
• Support method qualification by creating QC test methods and performance of method qualifications
• Review QC data generated from method qualifications, stability studies and GMP testing
• Plan, coordinate and own preparation/aliquoting of custom critical reagents manufactured internally for use in GMP testing methods
• Support logistical aspects of GMP stability programs for drug substances and drug product

Basic Qualifications:

• BS/BA degree in biology, chemistry or related field with 0-2+ years of industry experience, or MS degree with up to 2 years of experience.
• Experience in Analytical Development or Quality Control roles supporting GMP testing/manufacturing of cell therapy, gene therapy or gene editing products
• Experience with molecular-based assays (i.e., qPCR, ddPCR, gel electrophoresis) and plate-based assays (i.e., 96-well assays using DNA/RNA-binding dyes, kits for process residuals).

Preferred Qualifications:

• Experience or desire to learn HPLC/UPLC methodologies used in a GMP-laboratory.

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.