Executive Director, Biologics Analytical Research and Development GMP Operations Lead

Job Description

The Executive Director of Biologics Analytical Research & Development (AR&D) GMP Operations is responsible for providing strategic and technical leadership for the validation, implementation, and technology transfer of analytical test methods to enable the biologics clinical development pipeline, including oversight of the execution of analysis for release and stability testing globally.

The Executive Director reports directly to the Associate Vice President, Biologics AR&D and will be directly responsible for a team of people managers and scientists, approximately 75-100 people across our campuses in West Point, PA, Kenilworth & Rahway, NJ, Schachen Switzerland and Dunboyne Ireland. The team works closely with leaders and scientists within the Analytical and Process Development, Manufacturing, Quality Assurance and Regulatory groups. They provide direct oversight and are accountable for receiving analytical methods from our development teams, validating to GMP standards and executing the release/stability supportive studies to drive our portfolio of products from candidate nomination to marketing authorization.

The Executive Director manages the work within their group to ensure that the goals of the project teams are met in a timely, cost-effective, phase-appropriate, and compliant manner. They are accountable for the growth/career development and performance of the team with a demonstrated ability to collaborate, build high-performing teams, develop diverse talent, set and achieve a strategic direction for the team and implement and manage change to enable process improvement and optimal workflows.

Responsibilities include, but are not limited to, the following:

Scientific Excellence & Innovation: Responsible for leading the overall scientific, technical and operational efforts of a department within Biologics AR&D with execution of Biologics analytical validation to enable installation of release and stability assays across our laboratories. The lead will also be responsible for managing the capacity across our internal testing laboratories in the biologics space and ensuring fluid utilization of subject matter expertise to drive alignment, consistency and creative problem solving to enable scientific and operational excellence. Quality and Regulatory Standards: Develops and implements quality standards and specifications for Drug Substance and Drug Product. Ensures the delivery of high-quality CMC sections for IND/CTA/NDA filings. Addresses measurement and quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications. Compliance Systems: Sets a high standards for compliance and ensures that systems and resources are in place to conduct the activities of the laboratories in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, and OSHA safety standards and in accordance with corporate requirements. Partners with colleagues to ensure overall laboratory readiness for regulatory inspections and internal audits. Project Management and Teamwork: Responsible for managing quality and timelines to support on time validations, release and stability analysis and investigations. Facilitates teamwork and coordinates execution of plans with key stakeholders. Allocates resources and ensures tracking and follow-up as necessary. Ensures the department works as a partner with collaborators and teams. Building Teams & Talent: Responsible for setting high standards, building and managing a high performing team. Sets department goals and performance objectives, supports talent development and proactively addresses performance issues. Identifies department needs and recruits/hires/promotes talent as appropriate to grow and progress the organization. Allocates proper resources for meeting goals and objectives. Communications: Maintains productive communications with staff, colleagues across CMC development and commercialization, Quality Assurance, Technical Operations, and CMC Regulatory Affairs as needed to ensure understanding of needs, proper prioritization and timely delivery of product knowledge, customer-oriented data and documentation. Regularly exchanges ideas and information to develop effective plans and strategies to meet business needs.

Qualifications:

Education:

• PhD in relevant scientific discipline with 10+ years' experience; MS in relevant scientific discipline with 15+ years' experience

Required:

• 10 + years of product development experience
• Demonstrated ability in leading large analytical teams and mentoring and developing talent.
• Incumbent must have excellent interpersonal, communication, and collaboration skills.
• Strength in delivering results on firm deadlines in support of drug/vaccine development and commercialization

Preferred:

• Extensive GMP experience, including expertise in assay validation requirements, capacity optimization, integrating innovative approaches to quality facing laboratories and operational excellence.

THE COMPANY...

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrass, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company's medicines and vaccines, which supports our mission to save and improve lives around the world. Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients. We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" showing the company's commitment to our employees and the community around us.

Who we are ...

We are known as Merck & Co., Inc., Rahway, in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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.

For more information about personal rights under Equal Employment Opportunity, 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, 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:
$235,280.00 - $370,400.00

Available 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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:
Regular

Relocation:
Domestic/International

VISA Sponsorship:
Yes

Travel Requirements:
25%

Flexible Work Arrangements:
On-Site

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Requisition ID:R252631