Company Overview:
At Aditum Bio our mission is to give patients access to medicines that may not otherwise be developed. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis, Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies that for some reason are not advancing toward the clinic. The firm focuses on the translational phase of medicine (Phase I and Phase II) to generate data that can support full clinical development, and eventual market launch, to reach patients in need.
Position Summary:
The Senior/Executive Director Biologics CMC is responsible for leading the overall planning, oversight and execution of CMC operations for biologic assets in the Aditum Bio Portfolio Companies’ in all phases of development (pre IND-Phase III). This includes the strategic planning of the biologics CMC program with Portfolio Companies and Board of Directors, as well as executing together with our strategic partners and Contract Manufacturers.
Position Responsibilities:
- Develop CMC Strategy and Planning
- Collaborate with the Portfolio Companies to closely plan CMC programs (upstream and downstream manufacturing, drug product and analytical activities), from preclinical development through clinical supplies for Phase 3 registration studies, including projection of API/DP needs, budgets and timelines
- Develop and implement a strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP using CROs and CMOs
- Execute plans in accordance with cGMP, ICH and FDA regulations
- Partner with and maintain regular contact with key stakeholders including, Quality Assurance, Regulatory Affairs, Medical, Legal, Finance, and Project Management
- Write and review relevant sections for regulatory
- Build the organization to deliver quality systems and operations
- Oversee partner and vendor relationships and activities
- Identify, select and manage Contract Manufacturing Organizations (CMOs) for process optimization, nonGMP and cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs
- Ensure program execution and oversight
- Oversee the tactical implementation of the manufacturing programs, including delivery of scalable and cost-effective manufacturing routes that meet or exceed the target clinical profile
- Manage supply chain and logistics in support of clinical studies
- Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents
Qualifications:
- Advanced degree in science (e.g., chemistry, biotechnology, pharmaceutical sciences, or related discipline)
- Pharmaceutical/biotechnology industry experience (minimum 10 years) in managing US and International CRO/CMOs for the manufacture of non GMP and cGMP APIs and DP
- Experience with projects preclinical through Phase 3 including multiple dosage forms and multiple molecule types (proteins, antibodies; Cell and gene therapy experience a plus)
- Strong leadership skills with ability to be hands-on and lead/manage the CMC programs
- Thorough knowledge of cGMP manufacturing and IND, CTA and NDA filings; thorough and relevant knowledge of FDA and EMA regulations
- Strong skills in identifying and resolving critical issues
- Strong track record in effectively working with senior management
At the Senior Director level, the range for this full-time position is $245,000 to $265,000 dependent on previous experience plus a target bonus, equity compensation and benefits including medical, dental, vision, disability, life and 401k plan with match.
Our time off benefits include flexible/non-accrued PTO plus 12 paid holidays. Sick leave will also be accrued at the rate of one hour for every thirty hours worked. For employees eligible to take parental leave, we may provide up to 8 weeks of paid additional leave. Additional leave time may be available and may be paid from other sources.
Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience, relevant education and training, and other relevant factors. Please note the range reflects base salary and does not include target bonus, equity or benefits.
We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
