Director, CMC (Drug Substance) (Boston, MA)
- Oversight of CMC vendors, including adherence to quality, budget and timeline metrics.
- Collaboration with internal team and external partners and vendors to ensure integrated and quality driven production of drug substance to enable FIH (First In Human) regulatory packages and subsequent clinical studies.
- Proactive identification, communication, and appropriate mitigation of key CMC risks.
- Authoring of key elements of CMC regulatory documents and responses.
- Advanced scientific degree with at least 8-10 years of CMC experience in the biopharma industry.
- Strong scientific and technical track record in small molecule product development (drug substance process development, scale up, manufacturing and analytical testing).
- Demonstrated experience of management/oversight of CGMP activities (including technical review of master and executed batch records, oversight of manufacturing activities).
- Experience of management of contract development and manufacturing organizations.
- Familiarity with requirements for regulatory submissions in major global regions.
- Attention to detail, critical analysis of data/reports, and troubleshooting/root cause analysis abilities.
- Ability to adapt to and effectively manage change in a fast paced, lean, dynamic environment
- Outstanding verbal and written communication skills and strong organizational skills.
- This role is hybrid offering lots of flexibility and located in the Boston Seaport area
Recommended Jobs
Pharmacy Technician
Job Title: Pharmacy Floor Techncian Allmed Benefits: Vision Insurance, Health Insurance, Dental Insurance and 401(k) Pay Rate: $22/hr (Paid Weekly) Work Location: 140 Locke Dr C, Marlborough…
Perm Non-Invasive Cardiologist
Job Description: Full-time Permanent Noninvasive Cardiologist Physician needed in Bristol County Mass. Perm - Full-time Cardiologist/ EP BC/BE Skilled: Interpret EKG, Holter, Echocardiogr…
Graphic Designer
Job Description Job Description Robert Half's marketing and creative client is seeking a Graphic Designer for a 5+ month contract role. This fully remote, 20 - 40-hour-per-week opportunity requir…
Assistant associate or full professor department
Tufts University: Tufts School of Dental Medicine: Department of Orthodontics Location: Boston, MA Description: Tufts University School of Dental Medicine seeks candidates for a full-time p…
Sales Representative - Packaging
Job Purpose: Our Sales Representative will be responsible for developing and executing the sales strategy for selling Veritiv products and services within a designated geography or industry. D…
Flow Cytometry Tech I
Overview The DFCI Cytometry Cores provide expertise and access to cutting-edge conventional and spectral Flow Cytometry and Mass Cytometry in a shared use setting. The Cytometry Technologist I w…
Clinical Supervisor - RN Hybrid
Aveanna Healthcare is hiring a Nurse Supervisor in your area! Make a difference every single day by being a part of the delivery of unmatched clinical care for Aveanna’ s clients at home. Put your ma…
R&D Data Scientist
About Eight Sleep Eight Sleep is the world’s first sleep fitness company. Our mission is to fuel human potential through optimal sleep. We use innovative technology, detailed design, and proven scie…
CNC Applications and Service Manager - Machine Tool Builder
CMZ Machinery Group (previously imported under the Eurotech Elite banner) is a European leader in CNC lathe manufacturing, expanding its presence in the U.S. through CMZ USA. Our new facility in Broc…
Medical Assistant, Gastroenterology
**When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.** Under the general supervision of the designated supervisor (depending on the locati…