Director, Formulation Development job in Rahway
|Employer:|| Merck & Co.|
|State:||New Jersey (NJ)|
Requisition ID: PHA001462|
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck's Animal Health (MAH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry's most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.
The Director of Formulation Development, Pharmaceutical Sciences is responsible for leading the formulation development of small molecule products in the Merck Animal Health R&D pipeline across discovery through process definition and scale-up. This individual will be responsible for leading a dynamic and scientifically driven team, dedicated to design, development and characterization of robust drug product formulations as well as driving strategic decisions to identify, develop and implement those formulations into clinical and safety studies to advance development. The Director will be responsible for managing the work within his/her group and external service providers to ensure that the goals of the project teams are met in a timely, cost-sensitive, and phase-appropriate fashion. The incumbent is responsible for developing and aligning formulation development activities with project teams, overall development strategies and timelines and building the technical capabilities and collaborative scientific and operational partnerships needed to effectively carry out the organizational mission.
Responsibilities include, but are not limited to, the following:
• The Director is responsible for leading the overall scientific, technical and operational efforts of the Rahway Formulation Development department with delivery of products, processes, timely data, and process knowledge needed to meet project milestones.
• Collaborates closely with analytical colleagues to develop and implement specifications for drug substance and drug products in development and ensures the delivery of quality-related sections in CMC sections of regulatory filings.
• Responsible for quality, quantity and timelines for formulation projects and bringing formulation representation and expertise to project teams and task forces as appropriate. Facilitates teamwork and coordinates development and execution of risk-based development plans with key stakeholders. Allocates resources, forecasts budget requirements, and ensures tracking and follow-up as necessary.
• Responsible for setting high standards, building and managing a high performing group. Sets department goals and performance objectives, supports personnel development and addresses performance issues. Identifies department needs and recruits/hires/develops personnel as appropriate. Develops internal talent through coaching, training and job assignments that meet the needs of the organization.
• Maintains productive communications with staff, partners and stakeholders to ensure understanding of needs, proper prioritization and the timely delivery of product knowledge, data and documentation. Regularly exchanges ideas and information to develop effective plans and strategies to meet business needs. Establishes effective partnerships/relationships through collaboration. Encourages and supports collaboration across geographical regions and functions.
• Creates an impactful vision for the formulation department and communicates a supporting strategy to align people, resources and management within their department, cross-functionally, and at CROs or other partner organizations as needed.
• Encourages new ideas and processes, and encourages new approaches. Promotes a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication while delivering results with the proper blend of scientific rigor, development phase-appropriateness, and business acumen. Strives for continuous improvement. Sets high performance expectations and holds others accountable for the results expected.
• A Master's Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering or relevant scientific discipline with a minimum of ten (10) years of relevant experience, OR a PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering or relevant scientific discipline with a minimum of eight (8) years of experience.
• A minimum of ten (10) years of experience within formulation development.
• Thorough knowledge of cGMP/GLPs in the pharmaceutical industry.
• Thorough understanding of the regulatory requirements in CMC development with demonstrated acumen in writing regulatory filings culminating in product approval.
• Experience specific to animal health.
• Experience in pharmaceutical industry.
• Scientific knowledge and experience in formulation drug development and associated requirements throughout the discovery/development/commercial continuum
• Experience with a variety of packaging configurations.
• People management experience.
• Excellent leadership, managerial and problem-solving skills
• Demonstrated ability to identify, attract, develop and retain talent.
• Strong external network as evidenced through collaborations, publication, and patent history.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Visa sponsorship is not available for this position.
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Job: Pharma Process Development
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: Chemicals
Company Trade Name: Merck