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Sr. Research Associate – Discovery and Pre-clinical Support in Drug Substance, Drug Product & Manufacturing
$104k-131k (estimate)
Full Time 2 Months Ago
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Apogee Therapeutics is Hiring a Sr. Research Associate – Discovery and Pre-clinical Support in Drug Substance, Drug Product & Manufacturing Near Boston, MA

Role Summary

We are seeking a Sr. Research Associate who will be responsible for managing research-scale production, characterization, and distribution of protein-based biologics. This individual will be an important member of the Tech Ops team, primarily working collaboratively with the Research and Translational Medicine department to advance preclinical assets through drug candidate selection. This role will also support cell culture, purification, and/or formulation process development to advance clinical assets and enable robust manufacture of Drug Substance (DS) and Drug Product (DP).

Key Responsibilities

  • Interface with Research, Development, Quality, and Manufacturing colleagues to advance clinical programs from Discovery to FIH trials
  • Liaise with Preclinical and Translational team to identify production needs and timelines
  • Liaise with CDMOs and CROs to scope and plan lab- and small Pilot-scale production of preclinical assets, ensuring scalability of production for non-GMP materials
  • Ensure timely and scalable production of pre-clinical materials
  • Complete certificate of analysis, including execution of limited analytical assays
  • Distribute and ship non-GMP research materials to relevant internal and external groups
  • Track and maintain inventory of pre-clinical materials
  • Support cell culture, purification, and formulation process development studies
  • Analyze data to understand and optimize process performance
  • Author and review internal procedures, reports, and presentations
  • Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team

Ideal Candidate

  • Degree in a relevant discipline (e.g., biology, biochemistry, biochemical engineering or related field); ideally Master’s degree with 2-4 years of industry experience or PhD with industry experience
  • 3 years biologics discovery, development, and/or manufacturing experience
  • Experience managing CROs and/or leading tech transfer to CDMOs
  • Experience with cGMPs
  • Experience with advancing assets from pre-clinical into clinical studies
  • Demonstrated aptitude in collaborating cross-functionally with Research, Analytical, Process Development, and/or Supply Chain
  • Excellent communication skills
  • Ability to multi-task and keep pace with a fast-moving organization
  • Availability to participate in calls across multiple international time zones
  • Ability and willingness to travel up to eight times a year for companywide All Hands meetings as well as Tech Ops team meetings
  • Must be able to work in the Apogee Boston office a minimum of 3 days a week as this is a hybrid role

The anticipated salary range for candidates for this role will be $110,000-$120,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Job Summary

JOB TYPE

Full Time

SALARY

$104k-131k (estimate)

POST DATE

03/09/2024

EXPIRATION DATE

05/01/2024

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