The Manager is responsible for developing products for INDs and NDAs with minimal supervision that meets the expected FDA standards and can be successfully filed with USFDA. The primary focus will be on the development oral solid dosage form.
This US-based role reports to Associate Director, Formulation Development or above and is based in Pine Brook, NJ.
Primary responsibilities of this role include the following:
- Evaluate and help develop new platform and patentable technologies for NDA products.
- Conducts scientific literature search periodically on assigned projects
- Independently design experimental plans, executes the studies for routine development, scale-up/s and exhibit batches.
- Analyzes data and performs root cause analysis in trouble shooting.
- Participate in manufacturing of scale-up and submission batches
- Provides scientific and technical leadership in developing new products
- Prepare reports on project status, literature review, and technical issues and their resolution affecting the product development.
- Prepare product development reports, process development report and other relevant documents as required for IND and NDA filing.
- Is motivated to do what is expected, be a self-starter. Makes things happen
- Is efficient and effective in getting the work completed.
- Proactive, plans ahead, anticipates challenges accomplishes what is expected and adds value to the job.
- Is passionate about work and speaks to true thoughts and ideas.
- Quality oriented: Never compromise quality in efforts to deliver products to our customers and partners
- Complete all required in-house and external training to keep current on regulatory and industry changes
- Must be able to work in a cross-functional environment interacting with departments such as formulation, analytical, regulatory, biopharmaceutics, quality and project management.
- A Ph.D. in Pharmaceutical Science or related scientific field from an accredited college or university, and 8-10 years of related pharmaceutical R&D experience or an M.S. with 10-12 years of experience.
- Must have at least 5-7 years of NDA experience.
- Experience in drug substance selection, physico-chemical characterization and developing formulations for toxicological evaluations.
- Experience in formulation and process development of oral solid dosage forms from bench to pilot scale.
- Up to date information and knowledge of FDA’s requirements for IND and NDA’s, cGLP, cGMP related to pharmaceutical product development, manufacturing and documentation
- Well versed in scientific and personal computer hardware and software applications.
- Excellent written and verbal communications skills.
- Some travel required.
- Experience in working with CRO/CMO is a plus.
GMP DECISION-MAKING AUTHORITY
This position requires adherence to GMP.
We are an EEO Employer.