Director - Pharmaceutical Development - Lupin Pharmaceuticals - Baltimore

Job description
Reporting to the Vice President, R&D, will be responsible for directing and managing in-house formulation development activities in developing challenging generics including oral solid, ophthalmic, and topical products from early development to pre-commercialization. Successful execution of this role requires a strong scientific and innovative formulation approaches, development of practical QbD based scalable manufacturing solutions, regulatory fillings strategy, the ability to communicate and establish close collaborations with partners. The candidate will be responsible for timely development of products through generic and NDA 505(b)(2) filings.

Essential Duties and Responsibilities
Build, lead and develop new R&D capability for developing complex oral solids, ophthalmic and topical products.
Lead and manage a portfolio of strategic generic and 505(b)(2) based development projects and initiatives on sound scientific principals in accordance with agreed upon project timings while following applicable regulatory/GMP requirements.
Develop a strategic and tactical implementation plan for the pharmaceutical development from pre-formulation to clinical/registration batch manufacturing to regulatory INDs/ANDAs/NDAs filings.
Ensure the proper prioritization and timely completion of projects on budget.

Assist with hiring of new staff and develop staff technically as well as in soft skills.
Provide scientific leadership for the QbD based pharmaceutical development from pre-formulation to ANDA filings consistent with best practices in the company and in the industry.
Provide technical expertise around efforts for PIV formulations/approaches.
Proactively scan the external environment including Regulatory expectations to identify and evaluate technological developments/needs relevant to the business.
Work closely with internal business development group and provide scientific input on the portfolio selection and closely work with external customers to develop business enabling relationships.
Generate innovative solutions to complex problems through the use of multidiscipline and technical principles.
Assess and recommend most appropriate, cost-effective and efficient avenues to performing planned studies.
Establish appropriate quality control standards and specifications for the products.
Assist in preparation of relevant sections of CMC and other regulatory documentation.
Monitor CRO development activities in support of clinical programs and ensure them for meeting high quality and regulatory requirements.
Support all corporate and FDA audits.
Establish contacts with appropriate external resources, alliance partners and consultants as required to assist in the company’s R & D efforts.

Desired Skills and Experience
Ph.D. in Pharmaceutics and Bio/Chemical Engineering in preferred. Master’s degree or equivalent will be considered with substantial experience and a proven record of achievement.
Minimum 15+ years related industrial experience in development of complex/specialty orals, topical, ophthalmic products and having demonstrated success with emerging technologies, proprietary formulation approaches.
Demonstrated scientific proficiency in the area of physical pharmacy, pre-formulation, formulation development, and biopharmaceutics.
Solid knowledge of drug delivery approaches as relate to developing modified release oral solids and abuse-deterrent controlled substance products.
Proficient in the interpretation of and contribution to patents.
Experience in managing multiple projects with competing timelines.
Ability to interface with several diverse departments and cross-functional teams.
Proven track record of scientific achievement as demonstrated by a successful record of R & D accomplishments.
Goal-oriented, attention to detail, proven ability to complete projects on time and within budget.
Excellent team player.
Exceptional project management and leadership skills.
Strong communication (oral and written) communication and organizational skills.
A forward thinking, proactive person who can draw on past experience to make balanced and pragmatic decisions.
Superior computer proficiency, including standard office programs, presentation preparation, project planning tools and database searching.

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