Director, Biologics Development and Commercialization Team Lead (CMC Team Lead)
$173.2k - $272.6kFull-time
Merck
Job Description Role Summary: The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial product.-The specific role will be responsible for advancing the company's biologics portfolio. Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the following areas:
Biologics, Chemical Process Development, CMC Biologics, Collaborative Leadership, Commercialization, Cross-Functional Leadership, Decision Making, New Product Launch Strategies, Organizational Leadership, Pharmaceutical Industry, Process Improvements, Product Launches, Results-Oriented, Strategic Thinking, Supply Chain, Team Organization, Technology Transfer, Writing Technical Documents Preferred Skills: 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. 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 The primary location for this posting is:
USA - Pennsylvania - West Point Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is:
$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 . 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. Additional location(s) Compensation Information: 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 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 VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Hybrid Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
n/a Job Posting End Date:
10/29/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R421291
- Responsible for on-time, end-to end execution of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to-achieve uninterrupted long-term supply
- Lead DCT.- Critically assesses all team deliverables & fosters a learning and collaborative environment. -Prioritizes, interrogates and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen circumstances.
- Responsible to ensure the best science and most robust processes are used, working closely with DCRC.- As the Product TPL takes ownership for the products' technical processes and associated technical challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.- Conducts options analysis and provides recommendation to governance for endorsement.
- Represent CMC and effectively communicates across the governance bodies, stakeholders and teams.- Drives outcomes/decisions through influence, advocacy, & negotiation with stakeholders. Influences and challenges the product development team's strategy to ensure a robust CMC strategy is achieved.- Identifies options to balance Speed/Cost/Robustness & achieve target commercial product. -Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by working teams supporting the product.
- Comply with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Work collaboratively to drive a safe and compliant culture.
- Development and Commercialization Experience :- Demonstrated expertise of technical aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality, and Supply Chain from early development through to commercial manufacturing.- Deep understanding of connectivity between clinical, CMC, and HH to successfully launch a new product.
- Technical Depth and Breadth of Experience:-- Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC function and ability to navigate through uncertainty to favorable outcomes.
- Strategic Thinking/Enterprise Mindset:-- Understands and can articulate the "Big" picture, thinks strategically, and demonstrates a customer orientation.- Demonstrated ability to know how to ask the right questions to drive critical conversations to the best decision for the enterprise, considering options which balance speed, cost, and robustness.- Challenges team members to think beyond their area of expertise for the broader interests of the company and patients we serve.
- Problem Solving and Innovative Thinking:-- Gathers and analyzes data and effectively responds to new or complex situations, developing creative and innovative solutions to solve and mitigate complex problems.- Ability to leverage scientific expertise and growth mindset to interrogate data and foster debate within teams to enable innovative and robust problem solving.-
- Ability to Navigate Ambiguity:-- Able to operate and provide direction through ambiguity and adapt plans in the face of change, unexpected events, and/or new information.- Capable of both directive and consensus facilitation and awareness of when to apply each.- Leverages scientific data to make disciplined risk-based decisions and shown to be capable of discerning between risks worthy of escalation versus typical uncertainty associated with drug development, commercialization, and/or supply.
- Productive Communication:-- Plans and delivers ideas and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of the enterprise.- Capable of tailoring communications to audiences, including governance bodies, senior leadership, team members, and individuals with backgrounds.- Practitioner of active listening who consistently strives to understands others' perspectives, concerns, and ideas.
- Collaboration and Teamwork:-- Creates, leads, and sustains high performing teams, fostering an environment of open communication, enabling all team members to contribute their perspectives and collectively resolve issues.- Actively builds strong relationships with team members and key stakeholders to promote collaboration and seek robust perspectives.
- Drives Results through Accountability:-- Demonstrates effective leadership of team activities to ensure on-time, end-to-end project execution and delivery.- Drives accountability within teams to follow through on commitments, provides direct feedback when individuals are not meeting expectations, and closely partners with senior leaders to deliver on priorities.
- Influence:-- Ability to persuade and inspire others to take action, make decisions, or change their attitudes and behaviors.- Rapidly able to achieve trust with partners, enabling ability to navigate complex organizational dynamics to achieve their goals.
- Ownership:-- Exhibits a proactive mindset, a strong sense of initiative, and the willingness to take on challenges and see them through to completion.- Fostering a culture of accountability and resiliency within the team or organization and empowering others to take ownership of their roles and responsibilities.
- Bachelor of Science (BS) Degree in relevant engineering or science fields with fifteen (15) years of relevant experience, or Master of Science (MS) Degree with twelve (12) years of relevant experience, or PhD with ten (10) years relevant experience
- Strong cross divisional networking skills and capabilities
- Demonstrated functional and enterprise leadership, ability to influence at all levels of the organization.--
- Strong collaborative skills and the ability to work strategically and in a detail-oriented framework with all levels of management.
- Must have strong understanding of product management systems and tools, strong business and financial skills, ability to manage multiple programs and create a high-performance work environment
- Experience in Technical product stewardship
- Demonstrated track record of successfully commercializing multiple large molecule programs across a variety of platforms
- Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly
Biologics, Chemical Process Development, CMC Biologics, Collaborative Leadership, Commercialization, Cross-Functional Leadership, Decision Making, New Product Launch Strategies, Organizational Leadership, Pharmaceutical Industry, Process Improvements, Product Launches, Results-Oriented, Strategic Thinking, Supply Chain, Team Organization, Technology Transfer, Writing Technical Documents Preferred Skills: 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. 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 The primary location for this posting is:
USA - Pennsylvania - West Point Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is:
$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 . 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. Additional location(s) Compensation Information: 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 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 VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Hybrid Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
n/a Job Posting End Date:
10/29/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R421291
Vacancy posted 6 days ago
Similar jobs that could be interesting for youBased on the Director, Biologics Development and Commercialization Team Lead (CMC Team Lead) in Rahway, NJ vacancy
$173.2k - $272.6k
...DescriptionRole Summary:The Development and Commercialization Team (DCT) leader is... ...integrated stage-appropriate CMC development and commercialization... ...advancing the company's biologics portfolio.Correspondingly,... ...manner with proven ability to lead complex discussions,...SuggestedFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ10 hours ago$173.2k - $272.6k
...Director-level role leading the Development and Commercialization Team for biologics at Merck. Responsible for end-to-end CMC strategy execution, process development, regulatory filings, and commercial manufacturing readiness across multiple sites. Responsibilities...Suggested- Scorpion Therapeutics is seeking a Senior Scientist (R3) in Regulatory CMC Biologics to lead global regulatory strategies across development and post-approval for biologics products. You will develop and execute robust CMC regulatory plans, manage INDs, BLAs, and post-approval...Suggested
$180k - $270k
...company dedicated to the development and commercialization of treatments for... .... Kalaris’ lead asset, TH103, was... ...Kalaris’ board of directors, management team and investors include... ...intravitreal Fc-fusion biologic product from Phase... ...& formulation, CMC, and company meetings...SuggestedNight shiftKalaris Therapeutics
Berkeley Heights, NJ4 days ago- ...activities ranging from fundamental biological research to developing... ...is part of Genomic Medicine, Commercial located in the United States... ...discovery to delivery.What you’ll do:Lead the Americas commercial... ...managing talent to maximize team performance and customer impact...SuggestedHourly payFull timeRemote workWork from homeFlexible hours
Danaher Corporation
Newark, NJ10 hours ago $71.9k - $113.2k
...Merck's Biologics Process Research & Development group seeks an Associate Scientist to design and develop robust... ...processes for clinical and commercial biotherapeutics. The role combines... ...development, analytics, and manufacturing teams to advance the biologics pipeline...$71.9k - $113.2k
...deliver the next medical breakthrough. Biologics Process Research & Development (BPR&D) within our Research &... ...Development, Analytical, Formulation, and Commercial Manufacturing while providing a... ...work with a highly collaborative team of scientists and engineers to design...For contractorsWorldwideRelocationVisa sponsorshipFlexible hoursShift work$156.9k - $247k
...our Separations Sciences team, within the Analytical... ...supporting the development pipeline programs across... ...conjugates, adjuvants, biologics and other molecular entities... ...roadmaps aligned with CMC needs.Talent development... ...MentorshipPartner with the Director of Separation Sciences...Full timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ4 days ago- Merck & Co., Inc. seeks a Regulatory CMC Lead for the synthetic-moiety (drug-linker) of ADC and... ...regulatory leadership on cross-functional teams and be accountable for delivering regulatory milestones through product development and lifecycle management. Responsibilities...
- Merck seeks an Associate Scientist to join Biologics Process Research & Development (BPR&D). You will design, develop and execute robust upstream/downstream bioprocesses for early- to late-stage biologics, collaborating across R&D and manufacturing to accelerate scale-...
$130k - $160k
...accomplished Construction Superintendent to lead Class A commercial interior and tenant fit-out projects... ...and tenant fit-outs. As Wick’s development portfolio grows, there may also be opportunities... ...management. Many members of our team have been with Wick for 10, 20 and...Full timeContract workFor subcontractorWork at officeWick Companies, L.L.C.
Woodbridge, NJ2 days ago- Merck & Co., Rahway, NJ, seeks a Principal Scientist, Engineering to lead late-stage small molecule programs from development to commercialization. You will drive process characterization, technology transfer to commercial sites, and regulatory filing support while mentoring...
- ...a Principal Scientist, Engineering to lead late-stage small molecule manufacturing development, technology transfer, validation, and... ...assessments, GDP, and work with cross-functional teams to deliver robust, scalable processes for commercial supply. #J-18808-Ljbffr MSD
$255.8k - $402.7k
Job DescriptionThe Clinical Director (Principal Scientist) has primary... ...span all phases of clinical development (pre-clinical to post-... ...internal/external research project teams relevant to the development... ...group of experts in commercialization, regulatory affairs, statistics...Full timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ1 day ago$282.2k
Job DescriptionThe Senior Director (Sr. Principal Scientist) has... ...span all phases of clinical development (pre-clinical to post-licensure... .../external research project teams relevant to the development... ...functional group of experts in commercialization, regulatory affairs,...Full timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ4 days ago$173.2k - $272.6k
...bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior... ...and collaborative team of scientists and... ...multidisciplinary environment. Lead the development of... ...for successful commercialization. Improve upstream... ...of biologics CMC development....Local area- WSA - Wonderful Sound for All is seeking a data-driven Commercial Analytics professional to translate BI, CRM, and ERP data into actionable... ...Strong communication and training skills to share insights across teams are required. #J-18808-Ljbffr WSA - Wonderful Sound for All
$103k - $171.6k
...and capital planning. May supervise the work of interns and/or lead teams, providing performance feedback to management as appropriate.... ...personnel.Primary Responsibilities:Lead research and development of quantitative behavioral models used for credit risk, interest...Full timeWork experience placementWork at officeRemote workM&T Bank
Iselin, NJ3 days ago$255.8k - $402.7k
...Description The-Clinical-Director (Principal Scientist) has primary... ...span all phases of clinical development (pre-clinical to post-... ...internal/external research project teams relevant to the development... ...group of experts in commercialization, regulatory affairs, statistics...Full timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift workMerck & Co.
Rahway, NJ7 days ago- ...Therapeutics, Inc. in Berkeley Heights, NJ, seeks a Director/Senior Director, Drug Product Development to lead strategic and technical development of an intravitreal Fc-fusion biologic from Phase 3 through commercial launch. This role oversees formulation development,...
- ...Green Life Science is seeking a CMC Project Manager for Europe to lead strategic client programmes from a remote EU base. You will bridge clients and global technical teams, navigating CMC activities while delivering an exceptional customer experience. The role requires...Remote job
$204.25k - $312k
...Introduction Axtria is a leading global provider of cloud software and data analytics... ...companies transform the product commercialization journey to drive sales growth and improve... ...talent to join our rapidly growing global team. People are our biggest perk! Axtria is...Hourly payFull timeAxtria, Inc.
Berkeley Heights, NJmore than 2 months ago- National Building Supply - Belford in Belford, NJ, is seeking a high-energy Commercial Sales Executive to grow a multi-million dollar territory in the roofing and building products market. You will identify opportunities, build client relationships, and execute strategic...Work at office
- ...Insurance Associates is seeking a Senior Client Manager to independently serve as the primary service contact for a book of select commercial clients, ensuring client satisfaction and strategic planning. You will evaluate exposures, obtain quotes, review and finalize...
$204.25k - $312k
Axtria - Ingenious Insights in Berkeley Heights is seeking a Commercial Solutions Global CoE Leader to innovate AI-powered solutions in the life sciences sector. This role requires deep knowledge of pharma commercial operations and a proven background in building solution...- ...Danaher operating company, is seeking a seasoned sales leader to head the Americas commercial organization in a fully remote U.S. role. You will drive revenue, build a high-performing team, and align Operations, Supply Chain, Marketing, and Customer Service to deliver an...Remote job
- Role: Principal Scientist leading Separation Sciences within Analytical Enabling Capabilities in Rahway, NJ, supporting drug development across modalities including small molecules, biologics, peptides, and ADCs. Responsibilities: provide scientific leadership in chromatography...
$104.7k - $154.7k
...chef d’équipe de données (Data Team Lead, DTL), de chef de programme,... ....Provide training and development on data management expertise... ...'s Degree Health, clinical, biological, or mathematical sciences, or... ...clinical research services, commercial insights and healthcare intelligence...Full timeContract workTemporary workPart timeWork at officeLocal areaImmediate startWorldwideDay shiftIQVIA
New Brunswick, NJ2 days ago$168.2k - $252.4k
...a federally funded research and development center (FFRDC), we are broadly engaged... ...systems for defense, civil and commercial customers. When you join our team, you’ll be part of a special... ...(GDO) is seeking a Systems Director to lead the Space Vehicle engineering team...For contractorsWork at officeImmediate startRemote workRelocation packageFlexible hours- ...chosen to use us as their Prime Contractor. We build Retail, big box, industrial, healthcare, K-12, higher ed, and other private commercial projects! If you are a Construction Superintendent w/ 5+ years of ground up construction experience then please apply! Looking...For contractorsLocal areaFlexible hours
Jobot
New Brunswick, NJ1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Biologics Development and Commercialization Team Lead (CMC Team Lead). Be the first to apply!
Related searches
- director of international development Rahway, NJ
- director learning & development Rahway, NJ
- development director Rahway, NJ
- head of learning & development Rahway, NJ
- director of web development Rahway, NJ
- research and development chef Rahway, NJ
- development manager Rahway, NJ
- research and development manager Rahway, NJ
- development chef Rahway, NJ
- senior director clinical development Rahway, NJ