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Director, CMC Team Lead

Bristol Myers Squibb Company

This is a Contract position in Jersey City, NJ posted April 3, 2020.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.

We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment.

We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The CMC Team Lead is responsible for developing and leading comprehensive, compound-specific, development strategies and tactics aligned with global Development Project Team objectives and incorporates all elements across the drug substance, drug product, analytical, quality, regulatory and clinical material space.

The CMC Team Lead is accountable for proactive generation and implementation of strategic and tactical CMC development plans including acceleration, deceleration, risk/issue identification and mitigation, as well as project level sourcing recommendations.

Responsibilities will include, but are not limited to: Responsible for multiple assets (large molecule, including ADCs, or small molecule/ASO/peptide) with the specific number depending upon stage of development and technical complexity.

Represents the Product Development organization on global Development Project Teams.

Ensures an effective Target Product Profile is in place which adequately defines the product characteristics and performance expectations to inform pharmaceutical development work.

Provides leadership to an interdisciplinary, matrix team responsible for developing integrated CMC strategies that drive global Development Project Team objectives and incorporates all elements across the drug substance, drug product, analytical, quality, regulatory, and clinical material spaces.

Accountable for ensuring specific functional deliverables are in place and on-track to support candidate nomination, First-in-Human, pivotal, and intended commercial formulation and manufacturing processes with appropriate control strategies.

Ensures appropriate formulation development, scale-up, production strategies, and timelines are in place to meet clinical supply, registration needs, technology transfer, validation, and global regulatory filings while meeting or exceeding industry standards.

Communicates effectively and transparently with functional heads within Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing, etc.) across the company.

Promotes a “One-Team Culture” among the CMC functional members, ensuring the CMC Team operates within the mission and values of Product Development and Bristol Myers Squibb.

Maximizes alignment, cooperation, input, decision making, commitment and synergy, of CMC Team members to ensure their technical contributions, meet and exceed program objectives.

Provides committed and inspiring CMC leadership, stewardship, and advocacy, striving for formulation and manufacturing process knowledge development, continuous improvement, acceleration, risk assessment and mitigation, resource allocation and support, as appropriate.

Promotes best practices and leads improvement opportunities.

The CMC Team Lead may support Due Diligence activities.

Skills/Knowledge Required : Advanced degree in a technical discipline (e.g., biology, chemistry, pharmacy, engineering) that is relevant to pharmaceutical development and manufacturing of small molecule and/or biological drugs.

Minimum 10 years of experience in either small molecule or large molecule pharmaceutical development with an established record of functional/CMC excellence and influence as well as demonstrated excellence leading CMC Teams or other matrix teams.

Solid understanding of how pharmaceutical development integrates and partners with Quality, Regulatory CMC, Non-Clinical, Clinical, and other functional areas Track record of successful pharmaceutical product development Proven leadership ability to align, motivate and empower team members Demonstrated ability for critical thinking and innovation Strong sense of value for investment and ability to develop cost-effective development plans Effective communication, collaboration and negotiation Ability to engage and align other stakeholders outside the project team Accountability for design and delivery on complex development plans Ability to understand and communicate risks as well as developing and executing contingency plans for development programs Ability to manage ambiguity, and make sound scientific and business decisions with limited information (when necessary) Proven ability to work effectively with cross-functional stakeholders in a complex / changing /global environment Ability to manage projects that have a potential combination of partnership/alliance or external efforts Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.

We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.