Dir, Engineering, CMC Leader for Biologics

Job Description

The Development and Commercialization Team (DCT) leader isaccountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial specific role will be responsible for advancing the companys biologics portfolio.

Correspondingly the DCT leader will be responsible for delivering world class outcomes in the following areas:

• 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 toachieve 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 teams 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.

• Compile with our companys 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.

Core Competencies:

• 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 diverse audiences including governance bodies senior leadership team members and individuals with diverse 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.

Minimum Educational Requirement and Experience:

• 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

Required Experience and Skills :

• 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

Preferred Experience and Skills:

• Experience in ADC development and commercialization.

• 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

• Expert knowledge in QbD

Required Skills:

Accountability Accountability Active Listening Applied Engineering Capital Management Change Management Chemical Process Development Commercialization Communication Strategy Development Corporate Productions Cost Management Cross-Cultural Awareness Cross-Functional Leadership Cross-Functional Teamwork Decision Making Drug Development External Manufacturing GMP Compliance Innovation Leadership Life Science Management Process Manufacturing Scale-Up Mitigated Risks Options Analysis 14 more

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 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:

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 anothers thinking and approach problems collectively.

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 Monday - 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 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.

The salary range for this role is

$169700.00 - $267200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

12/4/2025

*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.