Director, Operations - API
BioSpace
Get a reply from this employer
Your resume and cover letter, tailored to exactly what they’re hiring for.
Benefits offered by this job
Job summary
BioSpace is seeking a Director, IPT Leader for the Elkton, VA API operations. You will shape the future operating model, drive site ramp-up, and lead cross-functional teams to ensure safe, compliant, and efficient API production.
The role emphasizes strategic planning, governance, and performance management within a fast-paced, regulated environment. Strong Lean Six Sigma and leadership experience are valued.
Qualifications
- Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering, or related field.
- 10+ years of relevant experience in pharmaceutical or regulated manufacturing.
- Experience leading teams with direct and indirect reports.
- Strong knowledge of cGMP, quality systems, regulatory readiness, and safety practices.
- Experience with operational planning, project leadership, or site ramp-up/start-up activities.
- Leadership experience in Manufacturing, Technical Operations, Quality Operations, Engineering, or Production Planning.
- Proven ability to lead in complex environments and manage multiple priorities across functions.
- Experience with Lean Six Sigma and structured problem-solving tools.
Responsibilities
- Lead Site Leadership Team alignment of IPT priorities with site and company strategy.
- Develop future-state operating model for Elkton API operations and ramp-up.
- Oversee safe, compliant, and reliable API operations, drive performance reviews and continuous improvement.
- Assist in budget planning and identify opportunities for productivity and cost improvement.
- Promote quality culture and ensure cGMP compliance and deviation management.
- Lead talent development, coaching, and succession planning within the IPT.
Skills
Education
Tools
Job description
At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.
At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence. At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.
The Director, IPT Leader, API provides leadership, technical and operational expertise to the Integrated Process Team (IPT) supporting the API manufacturing value stream at the Elkton, VA site. This role is accountable for shaping the future operating model for our new small molecule pharmaceutical manufacturing facility, including project and site readiness, organizational design, and the establishment of operating rhythms, governance, IPT culture,Ways of Working, and performance standards. In the early project phases, the incumbent will lead strategic and tactical planning, cross-functional coordination, and project management activities required to support successful site build-out and operational ramp-up. As the site matures, the role will transition into full IPT leadership, accountable for safe, compliant, reliable, and efficient API operations, delivery performance, continuous improvement, stewardship, and people development. The incumbent serves as a member of the site leadership team and ensures alignment of site priorities with divisional and company strategies.
- Serve as a member of the Site Leadership Team and help align IPT priorities with site and company strategy.
- Provide direction to establish tactical and strategic plans that support API ramp-up and long-term operational success.
- Partner across the site and with above-site teams to ensure strong coordination, decision-making, and execution.
- Represent the IPT and the site as needed with internal stakeholders and external partners.
- Lead the development of the future-state operating model for the API operations at Elkton, VA.
- Support site start-up, ramp-up, and operational readiness activities through project leadership and cross-functional coordination.
- Help define organizational structure, organizational culture, operating rhythms, governance, and capability needs for the evolving site.
- Ensure readiness plans, risk assessments, and implementation plans are developed and executed effectively.
- Ensure safe, compliant, and reliable and RFT API operations in support of production and supply objectives.
- Lead operational reviews and daily management routines to maintain visibility to performance, issues, and priorities.
- Drive structured problem solving and the use of performance metrics to identify trends, action plans, and opportunities for improvement.
- Support production planning, resource deployment, and issue resolution to meet site objectives.
- Promote lean thinking and continuous improvement to improve flow, throughput, right-first-time performance, and operational stability.
- Support and/or own budget planning and financial stewardship for the IPT, including operating and capital spend.
- Partner with site leadership to identify opportunities for productivity, efficiency, and cost improvement.
- Ensure resources are allocated effectively to support current and future business needs.
- Promote a strong quality culture and support a state of permanent inspection readiness.
- Ensure cGMP compliance and effective management of deviations, investigations, and corrective actions.
- Partner with Quality, EHS, Engineering, Technical, and Supply Chain teams to support site priorities and maintain strong compliance standards.
- Ensure appropriate training, documentation, and change management practices are in place to support safe and compliant operations.
- Champion a strong safety culture and support risk management activities across the IPT.
- Lead, coach, and develop a team of leaders and contributors to build a high-performing organization.
- Foster a culture of accountability, collaboration, empowerment, and continuous learning.
- Support talent development, succession planning, and ongoing skill-building within the IPT.
- Communicate clearly and regularly to align the team around priorities, expectations, and performance.
- Bachelor’s degree required. Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering, or a related scientific/technical discipline is preferred.
- 10+ years of relevant experience in pharmaceutical or other regulated manufacturing environments.
- Leadership experience in one or more of the following areas: Manufacturing, Technical Operations, Quality Operations, Engineering, and/or Production Planning.
- Experience leading teams with direct and indirect reports.
- Strong knowledge of cGMP, quality systems, regulatory readiness, and safety/environmental practices.
- Demonstrated experience with operational planning, project leadership, or site ramp-up/start-up activities.
- Proven ability to lead in complex environments and manage multiple priorities across functions.
- Strong business acumen and experience with financial stewardship and resource planning.
- Experience applying Lean Six Sigma, continuous improvement, and structured problem-solving tools.
- Effective communication, coaching, and change leadership skills.
- Master’s degree in Science, Engineering, Business, or a related discipline.
- Experience in small molecule API manufacturing or commercial pharmaceutical operations.
- Prior experience supporting a manufacturing site start-up, transformation, or ramp-up.
- Experience developing future-state operating models, organizational structures, or operational governance systems.
- Lean Six Sigma certification or deep practical application of Lean tools.
- Experience in a highly matrixed global manufacturing environment.
- Demonstrated success in talent development, employee engagement, and succession planning.
- Experience with capacity planning, capital planning, supply planning, and S&OP.
- Familiarity with inspection readiness, deviation management, and broader quality systems in a regulated environment.
- Adaptability
- Adaptability
- API Manufacturing
- Biopharmaceutical Industry
- Business Acumen
- Business Agility
- Capacity Planning
- Capital Planning
- Data Analysis
- Decision Making
- Financial Budgeting
- Lean Manufacturing
- Manufacturing Quality Control
- Operational Excellence
- Organizational Culture
- People Leadership
- Plant Turnaround
- Process Optimization
- Production Management
- Production Scheduling
- Project Leadership
- Project Management
- Regulatory Compliance
- Results-Oriented
- Six Sigma {+ 3 more}
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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
USA - Virginia - Elkton
Where required by law, the compensation range for this role is provided below.
$173,200.00 - $272,600.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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.
Regular
Domestic/International
Yes
10%
Not Applicable
Not Indicated
No
n/a
11/16/2026
- A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
