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Associate Director, QC Technical Support
4 months ago
The Quality Control Associate Director will be responsible building and managing the Technical Support sub-function within Tessera's growing Quality Control team. We are searching for a driven, enthusiastic and self-motivated individual who is able to build a team while also contributing individually.
The successful candidate will work as part of the Quality Control team to ensure readiness of in-process, release and stability test methods for Tessera drug substances/ products and phase I/II clinical programs.
Key Responsibilities:
- Build / Manage Technical Support sub-function and personnel within Quality Control team
- Manage method qualification and verification activities for phase I/II clinical programs including processes, project-specific documentation and cross-functional communication
- Own method qualification protocols/ reports and standard operating procedures for internally and externally performed QC methods used for drug substances and drug products
- Manage Tessera's QC critical reagent program and reference standard program
- Manage method lifecycle activities including method trending and remediation throughout product lifecycle
- Bachelors degree, at minimum, in biology or related field with at least 8 years of industry experience is required.
- Extensive experience in method development, qualification and/or validation of GMP methods used for clinical and commercial phases
- Previous experience in maintaining / remediation of QC methods across product lifecycle (i.e. method trending, method investigations or remediation's)
- Strong understanding of regulatory guidance for method validation and verifications including ICH, USP, FDA and EU
- Previous laboratory experience with a diverse set up analytical skills including HPLC, ddPCR/PCR, plate-based/ELISA assays is a must
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.
More about Tessera Therapeutics:
Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. Tessera provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with Tessera regarding a reasonable accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied, please contact the recruiter or Accommodations@tesseratx.com
Recruitment & Staffing Agencies: Tessera Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Tessera Therapeutics or its employees is strictly prohibited unless contacted directly by Tessera Therapeutics' internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Tessera Therapeutics, and Tessera Therapeutics will not owe any referral or other fees with respect thereto.
