Associate Director, oral drug development

This person will carry out and/or supervise research and development tasks pertaining to fresh pharmaceutical products and support ongoing pharmaceutical products for injectable, oral solid, and other complex dosage forms. All phases of product development, such as pre-formulation, formulation, scale-up, and knowledge transfer activities, will be carried out and/or managed by the individual. The person will plan research, examine and understand information of various degrees of complexity, and offer suggestions. The person will create the submissions' required regulatory papers.

ESSENTIAL FUNCTIONS: Responsibilities include oral solid and/or injectable product CMC development for ANDA and 505b2 applications.
Create and carry out research for the development of pre-formulation, formulation, processes, sterilisation, scaling-up, stability, and container closures.
Use sound scientific principles and innovative problem-solving techniques to address challenging formulation, stability, manufacturing, and other technical problems.
Locate and oversee CRO/CDMO organisations to boost development productivity and efficiency.

 Oversee production activities related to technology transfer, scale-up, and batch registration.thorough knowledge of pharmacokinetics data analysis and bioequivalence study design.
For ANDAs, NDAs, and other regulatory dossiers, prepare technical reports, presentations, and CMC materials.
In order to support regulatory submissions, oversee CMC development activities and write or review CMC sections.
Create CMC strategies to support biowaiver and reduced stability testing, and prepare replies to CMC information requests and deficiencies.
Independently manage the development of innovative products from the lab bench to market.
Go over all relevant technical documentation to identify potential new projects.

The primary suppliers of DMF API, excipients, tools, and packaging materials should be screened and identified.
In order to facilitate the regulatory filling of ANDAs and 505b2s, functional activities must be identified for projects and estimates for timetables and resource requirements provided. Activities in the functional area must also be coordinated.
In cross-functional project teams, represent the formulation function.
To hasten the development and FDA approval of new goods, coordinate with a variety of organisations, including those developing analytical methods, quality control, regulatory affairs, quality assurance, production, and buying departments, among others.
Examine and update departmental SOPs and other technical documents Perform any additional tasks or assignments that come up.

Education/Experience: PhD in pharmaceutical science, chemical engineering, chemistry, or a related field with at least 5 years of experience in the pharmaceutical industry; or MS in pharmaceutical science, chemical engineering, chemistry, or a related field with at least 8 years of experience in the pharmaceutical R&D sector.
Skills/Qualifications:
It is essential to have experience developing generic and/or 505b2 NDA products.
Excellent technical expertise in physical chemistry, polymer science, and pharmaceutical science.
Extensive, practical product development experience in oral solid dosage forms and/or injectables at the lab and commercial scales. An advantage would be knowledge of more complex dosage forms, such as long-acting injectables, nasal, topical, etc.

In-depth understanding of cutting-edge drug delivery technologies and their uses in medicine, including emulsions, suspensions, polymers, nanoparticles, and colloidal systems.
Thorough understanding and practical experience with pharmaceutical dosage forms, cutting-edge drug delivery methods, and pharmacokinetics.
Becoming familiar with legal specifications like ICH and FDA rules.
Exhibit leadership potential and strong verbal and written communication abilities.
DEA restricted substance handling experience is desired.
A track record of collaborating with and managing cross-functional project teams.

Workers are required to wear eye protection and lab coats when in the lab area, which is air conditioned and environmentally controlled.
The individual may operate with poisonous or caustic chemicals and may periodically lift and/or move up to 25 lbs.
Must pass a background check and a drug test. Able to travel domestically and abroad for up to 25% of the time.

Kind of Work: Full-Time
Benefits: Dental insurance, 401(k) matching, and
Adaptable timetable
health protection
Unpaid time off
vision coverage
Additional salary categories:

Able to commute  or relocate Bonus:

Master's Experience (Preferred):
 

TGI Life Sciences is acting as an Employment Agency in relation to this vacancy.