What are the responsibilities and job description for the Director, Oligonucleotide CMC position at Tessera Therapeutics?
Your experience includes…
- PhD or MS in relevant field with 10 years of experience in the biopharmaceutical industry.
- Expertise in oligonucleotide synthesis, scale-up, and purification process.
- Leveraging in-process analytical characterization methods, CPP, CQAs etc. to assure robust scalable manufacturing control.
- Managing external development or technology transfer of synthesis and purification methods.
- Tracking record of manufacturing per GMP requirements, including the engagement of CRO and CDMO capabilities.
- Authoring of relevant CMC sections of IND, NDA/BLA and other regulatory filings related to oligonucleotide therapeutics. Participating in health authority interactions
- Driving novel oligonucleotide chemistry and processes to improve research candidates.
- Strong organizational leadership skills with a proven track record in managing programs and cross-functional development teams.
- Excellent written and presentation skills.
- Prior experience with long oligos via chemical or enzymatic synthesis routes is very desirable.
You are interested in…
- Defining and optimizing oligonucleotide process and analytical control strategies and managing project timelines, budget and development teams.
- Leading external manufacturing of oligonucleotides with CMOs to support GLP tox studies and IND submissions.
- Independently leading both internal team and external CRO partners.
- Mentoring and coaching junior scientists.
- Working effectively with a cross-functional and highly collaborative biology, technology, and chemistry team to contribute to the delivery of key organizational goals/milestones.
About you:
You are an experienced leader with a proven track record of scientific excellence in the oligonucleotide chemistry space. You have experience contributing to regulatory filings (IND/BLA) and a strong understanding of GMP requirements. Your technical expertise includes oligonucleotide synthesis and purification as well in-process analytical characterization methods for scale-up.
Tessera leaders are empathetic and transparent coaches with a strong sense of integrity. They are committed to the growth and development of their teams, the organization and themselves.
Leadership Structure:
All inquiries regarding the posted position should be directed to the Talent Partner (see below). Interested individuals must apply directly to be considered for the opening.
This position reports to: Sandeep Nema – Senior Vice President, Technical Development
Meet our Leadership Team and Board of Directors
Meet your Talent Partner:
Narissa Furtado-Cordeiro - Manager, Talent Acquisition
Tessera offers a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits currently include group medical, vision and dental coverage, group life and disability insurance, 401(k) with company contribution, tuition reimbursement, and much more.
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.
