Lead, Oligonucleotide CMC

Reposted 14 Days Ago
Be an Early Applicant
Somerville, MA
Expert/Leader
Biotech
The Role
The Director of Oligonucleotide CMC will lead the development and manufacturing of oligonucleotides, overseeing synthesis, purification processes, and regulatory filings. Responsibilities include managing external partnerships, enhancing manufacturing processes, and mentoring junior scientists, while ensuring compliance with GMP and contributing to organizational goals.
Summary Generated by Built In

Your experience includes… 

  • PhD +4 or M.S. +6 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 required. 

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 professional 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 employees are creative and collaborative problem solvers. They have a strong sense of integrity and unwavering commitment to scientific excellence.   

Meet your Manager: 

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: Keith Jarvis Executive Director, Oligonucleotide Chemistry 

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 [email protected]

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.

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The Company
HQ: Cambridge, MA
262 Employees
On-site Workplace

What We Do

Our mission is to cure disease by writing the code of life

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