AddressJob Description
Our company is seeking a Vaccine Drug Product Development leader responsible for scientific and technical oversight of Vaccine Drug Product formulation design, process development, and innovation to establish and maintain a world-class team with expertise in Vaccine Drug Product Development. The incumbent is responsible for advancing a culture of scientific and operational excellence, identifying emerging trends in vaccine modalities and designing corresponding patient centric Drug Products through Phase 3 clinical development and line of sight to process validation and commercial launch. This role reports to the Associate Vice President, Sterile Products Development, and supervise 3-4 directors and supervise a staff of approximately 40-50 full time employees. This role can be located in West Point, PA, or Rahway, NJ sites.
Primary Responsibilities:
Oversee and drive scientifically sound formulation and process development basis for Vaccine Drug Products and adjuvants,including live virus vaccines and new modalities
Ensure application of advanced formulation and process development tools that satisfies stage 1 and stage 2 validation criteria and follows QbD principles
Oversee formulation and process scale up from first in human through line of sight to commercial production
Oversee and review CMC authoring activities for DP manufacturing
Ensure successful and effective technology and knowledge transfer from research to production sites
Ensure knowledge management and process monitoring activities to ensure appropriate process robustness
Identification and implementation of formulation and process improvements, including evaluation and implementation of innovative technologies to improve Drug Product deliverables
Develop and implement innovative solutions to process analysis and control throughout the lifecycle
Attract, lead, and develop a world-class team of scientists and engineers to advance Vaccine Drug Product Development
Education:
Ph.D. in pharmaceutical, biochemistry, chemistry, bioprocess engineering, chemical engineering or related fields is required.
Required Experience and Skills:
Ph.D. in pharmaceutical, engineering or related sciences with at least 15 years of experience in biopharmaceutical development and a solid record of achievement in roles of increasing responsibility.
In-depth knowledge and understanding of parenteral drug development process, and CMC related FDA and international regulations. Able to anticipate industry trends and emerging issues.
Demonstrated ability to develop and execute organizational/business strategy to bring maximum value to the organization
Demonstrated ability to effectively develop and lead high performing global organizations of industry leading and highly talented experts
Experienced in developing and implementing strategy to optimize processes and proactively manage risk
Strong strategic awareness and an ability to successfully navigate complex, matrix organizations
Lead a diverse team across fostering a culture of collaboration, excellence, and continuous improvement. Provide coaching and mentorship to support talent development.
Ensure adherence to all applicable regulations, guidelines, and quality standards, including cGMP, FDA, and other regulatory requirements.
Safety and Environment: Prioritize and maintain a safe work environment, implementing and monitoring safety protocols to protect employees and the surrounding community.
Budget and Resource Management: Develop and manage the budget, optimize resource allocation, and drive cost-effective practices while maintaining high-quality standards.
Technology and Innovation: Stay abreast of industry trends and advancements, evaluating new technologies and innovations for potential implementation to enhance manufacturing capabilities and business process simplification and speed to market
Proven experience (15+ years) in biologics or vaccine Product Development, manufacturing, with a solid understanding of fundamentals of formulation and process design.
Demonstrated leadership skills with experience managing and developing teams
Understanding of cGMP and other relevant regulatory guidelines
Strong problem-solving, innovation and decision-making abilities.
Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams
Strength in delivering results on firm deadlines
Ability to adapt to changing priorities and work under pressure in a fast-paced environment
NOTICE FOR INTERNAL APPLICANTS
In 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.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
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. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective 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, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$243,500.00 - $383,300.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
Domestic/InternationalVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/ARequisition ID:R290284
PDN-9bc759c1-3a2b-45bc-ba73-798241e09015
