Merck
Director Biologics and Biopharmaceutics
Merck, Rahway, New Jersey, us, 07065
Merck Director Biologics and Biopharmaceutics Rahway, New Jersey Apply Now
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to identify and isolate a molecule that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical breakthrough.The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics understanding of how formulation impacts exposure of compounds in humans spanning the oral and non-oral portfolio.The successful candidate:Should have a vision to develop a team, demonstrated leadership skills, biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory environment.Will be responsible for sub-functional strategic planning, coordinating, and execution of initiatives supporting the interfaces between the biopharmaceutics team and various discovery and development departments.Will need to collaborate in a fast-paced, integrated, multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions.Proactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics.The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists. The successful candidate will effectively partner with Biologics and Biopharmaceutics leadership and extended leadership teams to implement strategy, conduct scientific research, and resource programs in a phase appropriate manner. The incumbent will be responsible for the recruiting, appraisal, and development of personnel under her/his supervision to their full potential.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides and biologic modalities.Review and approval of data and technical documents including critical evaluation of predictive models.Ability to recruit, select, develop, and mentor talent.Strategic and critical thinking to advance biopharmaceutics strategy across the portfolio.Attention to technical detail.Build collaborations across internal departments and key stakeholders.Ability to lead and champion organizational structure and be a change agent when necessary.Manage the departmental budget and meeting the agreed upon spend.Qualifications:Education:Ph.D. in Pharmaceutics, Pharmacokinetics, Biopharmaceutical sciences, Pharmaceutical sciences or relevant field with minimum of 10 years of industrial experience.B.S. or M.S. in Pharmaceutics, Pharmacokinetics, Biopharmaceutical sciences, Pharmaceutical sciences or relevant field with minimum of 12 years of industrial experience.Required:Advanced knowledge in pharmacokinetics and understanding of principles of physiologically-based pharmacokinetic modeling.Strong knowledge of formulation development of small molecules.Relevant experience in pharmaceutical development with exposure to all stages and aspects of development (pre-clinical, clinical, and commercial).Strong influencing and communication skills.A track record of scientific publications in the field.Preferred Experience and Skills:Hands-on experience with physiologically-based pharmacokinetics modeling software (e.g., Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product development to commercialization.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week.Expected US salary range:$164,800.00 - $259,400.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.Employee Status:RegularRelocation:DomesticVISA Sponsorship:NoTravel Requirements:10%Shift:1st - DayJob Posting End Date:10/7/2024
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Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to identify and isolate a molecule that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical breakthrough.The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics understanding of how formulation impacts exposure of compounds in humans spanning the oral and non-oral portfolio.The successful candidate:Should have a vision to develop a team, demonstrated leadership skills, biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory environment.Will be responsible for sub-functional strategic planning, coordinating, and execution of initiatives supporting the interfaces between the biopharmaceutics team and various discovery and development departments.Will need to collaborate in a fast-paced, integrated, multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions.Proactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics.The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists. The successful candidate will effectively partner with Biologics and Biopharmaceutics leadership and extended leadership teams to implement strategy, conduct scientific research, and resource programs in a phase appropriate manner. The incumbent will be responsible for the recruiting, appraisal, and development of personnel under her/his supervision to their full potential.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides and biologic modalities.Review and approval of data and technical documents including critical evaluation of predictive models.Ability to recruit, select, develop, and mentor talent.Strategic and critical thinking to advance biopharmaceutics strategy across the portfolio.Attention to technical detail.Build collaborations across internal departments and key stakeholders.Ability to lead and champion organizational structure and be a change agent when necessary.Manage the departmental budget and meeting the agreed upon spend.Qualifications:Education:Ph.D. in Pharmaceutics, Pharmacokinetics, Biopharmaceutical sciences, Pharmaceutical sciences or relevant field with minimum of 10 years of industrial experience.B.S. or M.S. in Pharmaceutics, Pharmacokinetics, Biopharmaceutical sciences, Pharmaceutical sciences or relevant field with minimum of 12 years of industrial experience.Required:Advanced knowledge in pharmacokinetics and understanding of principles of physiologically-based pharmacokinetic modeling.Strong knowledge of formulation development of small molecules.Relevant experience in pharmaceutical development with exposure to all stages and aspects of development (pre-clinical, clinical, and commercial).Strong influencing and communication skills.A track record of scientific publications in the field.Preferred Experience and Skills:Hands-on experience with physiologically-based pharmacokinetics modeling software (e.g., Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product development to commercialization.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week.Expected US salary range:$164,800.00 - $259,400.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.Employee Status:RegularRelocation:DomesticVISA Sponsorship:NoTravel Requirements:10%Shift:1st - DayJob Posting End Date:10/7/2024
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