Specialist/Sr. Specialist, R&D Strategic Operations

• Coordinates, aligns, and monitors research and development activities for program-specific cross-functional plans and risks

• Coordinates project timelines to support R&D goals from both a technical and business operations perspective

• Supports outsourced development and clinical/commercial manufacturing activities, as it relates to business, contract, financial management, and/or operational efficiencies

• Manages the operational activities (schedule, timelines, cost) of the vendors, ensuring cost, quality, metrics, delivery and program objectives are met. Manages operational risk at the vendors

• Assists in CDMO site evaluation/selection, preparation of the request for proposal (RfP) and contracting process

• Partners with key stakeholders in the preparation and negotiation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements; provides guidance on drafting documents and works with legal to ensure documents are processed in a timely manner

• Serve as a program point-of-contact within R&D

• Facilitate communications between key science and management stakeholders, as needed

• Collaborates with multiple functional lines (R&D, Regulatory, Quality Assurance, Clinical, Legal, Finance) within the company

• Facilitates and schedules meetings with internal personnel, as needed, to ensure cross-functional participation on the project teams

• Collaborates with (may lead) internal cross-functional teams and vendors to determine development, clinical, and commercial manufacturing requirements, identify and mitigate key risks, and ensure that plans are executed as intended

Requirements:

• BS/BA degree in Chemistry, Biochemistry or related discipline and 4+ years of Pharmaceutical industry experience OR

• MS/MA degree in Chemistry, Biochemistry or related discipline and 2+ years of similar experience as noted above OR

• PhD in Chemistry, Biochemistry or related discipline and some relevant experience; may include postdoc experience. Hands-on experience executing and interpreting pharmaceutical analysis, and drug product unit operation processing is preferred

• Demonstrates solid level of understanding project / group goals and methods

• Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes

• Able to explain the process behind the data and implications of the results

• Strong knowledge of one or more scientific disciplines, becoming expert in one discipline

• Strong knowledge of scientific principles, methods and techniques

• Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools

• Ability to work as part of a team; may train lower levels.

• Excellent computer skills

• Strong communications, problem-solving, analytical thinking skills

• Detail oriented yet can see broader picture of scientific impact on team

• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency

• Strong project management skills

• Strong understanding of cGLPs and cGMPs relating to pharmaceuticals

• Must be self-motivated, detail-oriented, possess familiarity of physical & analytical techniques as they pertain to biopharmaceutical properties

• Ability to learn quickly and think independently

• Exhibit strong scientific and business acumen

• Demonstrated understanding of chemical and instrumental methods for analyses of development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials

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