Senior Research Associate/Research Associate III, Drug Product Development
Doylestown, PA
Scientific Research & Development – Research & Development /
Full-Time /
On-site
About IGM Biosciences, Inc.
IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites, compared to conventional IgG antibodies with only 2 binding sites. We have created unique IgM antibodies with high selectivity, affinity, and avidity that may redefine what is possible for therapeutic antibody medicines. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers and receptor cross-linking agonists. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology, immunology, and inflammation targets. For more information, please visit www.igmbio.com.
IgM Antibodies and Autoimmune and Inflammatory Diseases
Antibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases. We are committed to exploring how our IgM antibody platform's unique structure and binding properties can improve outcomes for patients with these serious conditions.
IgM Antibodies and Oncology
The potential of our IgM antibodies drives our focus on oncology. Leveraging the power of avidity and the strong and durable binding of our IgM antibodies, we are developing new treatment options for cancer patients. Our initial efforts in this field are centered around the broad application of IgM antibodies to activate receptors, triggering the programmed death of cancer cells.
Position Summary
IGM Biosciences is hiring a Research Associate III/Senior Research Associate level lab-based lead within Drug Product Research & Development, Manufacturing, and Supply to join our team supporting IGM programs. In this position, you will be responsible for the design and execution of Drug Product scientific research and development projects in collaboration with colleagues across business units and programs to support end-to-end Research & Development and Company goals. You will support and contribute to developing frozen, liquid, and lyophilized drug product formulations, processes, and analytical approaches to enable pre-IND, post-IND clinical, and BLA requirements. You will engage with all partner groups, including pre-clinical discovery, downstream drug substance development, analytical development, manufacturing, clinical supply, and regulatory colleagues.
Responsibilities:
- Support Drug Product formulation, stability, characterization and process development of monoclonal antibody Drug Product programs in early stage and late stage development.
- Support efforts to increase mAb protein concentration and enable IV and Sub-cutaneous administration.
- Conduct biophysical and biochemical characterization using industry standard, high throughput, and plate-based workflows.
- Prepare and manage all essential reagents, excipients, buffers, sterile products, and critical studies.
- Enthusiastic to apply QbD principles, DOE, GxP principles for Drug Product development.
- Review and prepare notebook entries, presentations, SOPs, protocols, reports, and technical documents.
- Analyze scientific/technical data and present data in project team meetings.
Qualifications:
- Level commensurate with experience.
- Senior Research Associate: MS with 4+ years, or BS with 8+ years of experience in Drug Product Development, including early and late-stage activities, preferably in the biotech/biopharmaceutical/pharmaceutical setting.
- Research Associate III: MS with 2+ years, or BS with 5+ years experience in Drug Product Development, including early and late-stage activities, preferably in the biotech/biopharmaceutical/pharmaceutical setting.
- Laboratory studies and execution of characterization testing are expected.
- Familiar with formulating and analyzing liquid, high-concentration, and lyophilized Drug Products. Preferably large molecules, including monoclonal antibodies.
- Familiar with executing Drug Product development activities to inform early and late-stage scale-up and manufacturing processes (i.e., thawing, filtration, mixing).
- Ability to manage routine activities across multiple projects and phases simultaneously.
- Strong partnering, interpersonal, and excellent communication skills are a must-have.
- Physical ability to lift to 40lbs and work at the lab bench or Biosafety cabinet for extended periods.
$70,000 - $115,000 a year
This range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location.
Actual individual pay is determined by demonstrated experience and internal equity alignment.
We offer a fast-paced, collaborative, team-based, work environment.
One of our top priorities is to maintain the health and well-being of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options:
· Medical, dental and vision insurance.
o The full premium amount for our employees and their dependents is covered by IGM
o FSA (Flexible Spending Account) or HSA (Health Savings Account)
· STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
o Voluntary Life Insurance and Disability
· 401(k) Plan with Employer Match
· 3 Weeks of Paid Time Off, 5 sick days per year, 12 holidays
· Cell phone & internet subsidy
· Employee Referral Bonus Program
· Annual training budget for professional development
· Commuter Benefit
· Annual bonus program
· New hire stock
o Annual refresh grants
· ESPP (Employee Stock Purchase Plan)
IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.
