Director Scientific Large Molecule Analytical Development Johnson & Johnson Philadelphia

Job Description:
The Analytical Development group is seeking a Scientific Director who will serve in the Large Molecule Value Stream (LM VS) Scientific Leader role, providing strategic and scientific guidance to teams and individuals responsible for the CMC development of large molecule therapeutics and their post-licensure life cycle management, including support of manufacturing investigations.

Responsibilities include but are not limited to: Provide strategic and scientific guidance in all CMC technical areas, in particular, serve as in-house large molecule analytical development expert, including structure-function relationships, test method development and validation and establishment of specifications; Guide teams in the preparation of technical reports and regulatory submissions, participate in their review and approval, and contribute to development of strategies to comply with US and international regulatory standards; Provide scientific guidance on complex manufacturing investigations; Lead discussions to identify new scientific/technical opportunities for the large molecule product platform, and negotiates/influences acceptance of new opportunities and concepts through scientific leadership; Support a learning environment and foster a culture of scientific excellence through training, influence and leading by example; Act as a senior internal expert with a direct impact on PDMS Large Molecule Value Stream business objectives. Key partners include API and DPD functional leaders, CMC-Leaders, Janssen supply chain platform leaders, Quality Assurance, Global Regulatory Affairs and Discovery.

Qualifications

Ph.D. in Biochemistry, Analytical Chemistry, Chemical Engineering or related discipline is required

At least 12 years relevant experience in biopharmaceutical development, licensure and post-marketing support is required

Primary in-depth experience and knowledge in large molecule analytics, as well substantial experience in other CMC functional areas (ie: Cell Culture, API Purification, Drug Product) is required

Demonstrated ability to develop and transfer biologics manufacturing processes and product testing that meet customer needs is required

Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and life cycle management is required

Experience with regulatory writing and submissions (ie: INDs, BLAs, etc) is required

A proven track record in leading scientific teams, including direct and/or indirect people management experience is required

Candidates must possess excellent oral and written communication skills

A proven ability to execute and get results in a matrix environment through leadership and accountability

Ability to foster team productivity and cohesiveness and to work collaboratively in a complex, matrix environment

Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organizational issues, structures and dynamics

Demonstrated ability to make difficult decisions in a timely fashion

Must have excellent follow through and organizational skills

Strong analytical problem solving skills and organizational skills

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