The Senior Manager, Drug Product Technology will be responsible for developing formulation and manufacturing processes for Radius dosage forms in all development stages including validation and commercialization. The successful candidate will have membership in CMC and other project teams and collaborate closely with other CMC leaders including Commercial Manufacturing, Supply Chain, CMC Regulatory, and Analytical Science, as well as with other functions.
Plans and oversees oral solid dosage formulation and manufacturing process development, scale up, and technology transfer activities at third party manufacturers from early development stage through validation and commercialization.
Responsible for writing and/or reviewing relevant sections of IND/NDA's and other regulatory filings.
Ensures alignment of process development and technology transfer activities with CMC and program development plans and current regulatory guidance.
Work in close collaboration with Supply Chain and Program Lead to ensure clinical supplies continuity for all Radius clinical studies.
Serve as subject matter expert in drug product supporting other functions (Legal, Business Development, etc).
Responsible for establishing solid oral drug product manufacturing infrastructure with systems that are consistent with accepted pharmaceutical quality standards in conjunction with other related functions.
Ensure the formulation and manufacturing process development is conducted in accordance with the most updated regulatory requirements including Quality by design principles.
PhD. in areas of Pharmaceutical sciences, Pharmaceutics, Industrial Pharmacy, Chemical Engineering or related fields.
Minimum 8 years of experience developing and scaling up oral solid dosage forms and manufacturing process in the Pharmaceutical Industry.
Proven ability to achieve results in an outsourced model utilizing external manufacturing facilities
Extensive experience in granulations technologies such as fluid-bed, high-shear, roller compaction, and extrusion. Prefer a working knowledge on solution formulations.
Proven track record in formulating new chemical entities with low solubility and/or permeability is highly preferred.
Strong knowledge of regulatory requirements related to oral solid dosage forms (Quality by design, SUPAC, ICH guidance's etc)
Experience with GMP manufacturing oversight, including batch record and change management.
Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment.
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.