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Job Description

The Technical Operations Director is accountable for the operation of the Technical Operations Department. The role will serve on the Site Leadership Team (SLT) and will be responsible for developing the strategic manufacturing/technical roadmap for the facility. As member of the SLT, the incumbent will play a key role in the development of policy and co-ordination of overall site operations. The role plays a critical part in strategic project realization of the Wilmington Biotech facility, a new hi-potent facility in our company’s Biologic manufacturing network, ensuring that site’s mission and objectives are effectively achieved, consistent with our company's requirements to ensure compliance, safety and reliable supply to our customers.

The Technical Operations Director is accountable for planning and on-time execution of commercialization activities of our pipeline products and routine clinical/commercial operations. This role will report into the AVP, Biologics Technical Organization, and will have the following functions reporting into the role:(1) Process Engineering (2) Site and Process Validation (3) Technical Operations support and (4) Technical Transfer activities.

Principle Roles & Responsibilities

+ Lead the site Technical Operations team. Identify, recruit and manage the Technical Operations Team at the site, implementing a strong quality culture and ensuring employee engagement and development in line with the site’s talent framework.

+ Strong department management including resource management, talent development, and day to day management of employees

+ Ensure that the team receives appropriate resources to develop technical and leadership skills, drive a high performing and inclusive culture, and stimulate personal growth and development in line with role.

+ Actively manage performance and develop team members to achieve organizational goals and employee personal and professional growth. Build a strong pipeline of talent and robust succession plans for key positions.

+ Develop annual operations financial plans, provide quarterly guidance on adherence, and manage all department operations within the targets established.

+ Manage technical teams to support new product commercialization, technology transfer, manufacturing, filing, and licensing of potent drug substances (DS) and drug product (DP) products, including Antibody Drug Conjugates (ADCs). Includes the sustained manufacturing and validated state of all products, processes, equipment, and technologies post-transfer.

+ Work with CPTL and key business partners to ensure the facility’s organizational design and operating model principles are aligned with our company’s organizational needs and platform processes to support future pipeline products.

+ Accountable for providing key input into all phases of facility startup-from facility, process, equipment, logistics and utility design to establishing systems and programs for routine manufacturing of cytotoxic and non-cytotoxic compounds, ensuring compliance through validation, operational readiness, and licensing/ launch of new products.

+ Responsible for implementing departmental operating policies, procedures and budget so that the technical operations team operates effectively to ensure right first-time execution and delivery of high-quality products manufactured at the facility.

+ Develop team organization structure, recruit, and on-board employees to build a competitive team that meets the project and production ramp up plan.

+ Actively partner with Operations, Quality, Supply Chain, Global S&T teams, R&D, GES, and Regulatory Affairs on new product introduction (NPI) to ensure that product quality, availability, and compliance with manufacturing processes are maintained within budget and delivered on time, while also providing support for regulatory filings.

+ Design and oversee process validation, qualification, and monitoring strategies, implementing master validation plans for processes, equipment, and facilities in collaboration with Subject Matter Experts and internal stakeholders.

+ Work across the Biologics Technical Operations organization to benchmark performance, share/adopt best-practices, and leverage network expertise to ensure process robustness and agility in operations.

+ Champion routine assessment of product performance/health, proactively identifying potential trends to enable intervention and mitigation well before supply interruptions.

+ Execute and improve the validation program for processes to ensure compliance with cGMP requirements and our company’s corporate quality policies and standards.

+ Responsible for the identification and implementation of scientific and technological improvement opportunities including both incremental industry advancements as well as transformational innovations.

+ Deliver major cost and quality improvements for the IPT aligned to the Operating Business Unit Strategic Roadmap, including the development of business cases, strategies, plans, timelines, and budgets for execution.

+ Ensures timely leadership and/or support of technical CAPA, including thorough investigations, root cause analysis and identification, and corrective and preventive actions to address root cause including developing/execution of change management and Kaizen efforts.

+ Provide direct technical support to the IPT for multiple processes and technologies. This support involves evaluation of raw materials including new suppliers, development of process fits, participation in campaign preparation and follow-ups. It also involves safety and HAZOP reviews, process monitoring, atypical investigations and resolutions including trending and prevention, defining cleaning processes for new production processes and review of the cleaning procedures/documentation.

Minimum Education Requirement and Experience:

+ Bachelor’s degree in Engineering, Science, Technical, or other relevant fields with twelve (12) years of demonstrated leadership ability and experience managing, coaching, and mentoring high-performing cross function teams in the pharmaceutical/biotech industry **OR**

+ Master’s degree in Engineering, Science, Technical, or other relevant fields with ten (10) years of demonstrated leadership ability and experience managing, coaching, and mentoring high-performing cross function teams in the pharmaceutical/biotech industry **OR**

+ PhD in Engineering, Science, Technical, or other relevant fields with eight (8) years of demonstrated leadership ability and experience managing, coaching, and mentoring high-performing cross function teams in the pharmaceutical/biotech industry

Required Experience and Skills:

+ Successful completion of the Personal Leadership Profile (PLP) Senior Leadership Assessment

+ Strong background in manufacturing/and providing technical oversight for biologic products including potent drug substances (DS) and drug product (DP) products, including Antibody Drug Conjugates (ADCs) following GMP standards.

+ Experienced in new facility operational readiness, facility, equipment and process design, and operation ramp up including organization, people and operation management system

+ Experienced in New Product Introduction, Technical Product Transfer, manufacturing process and investigation / change management

+ Experience in regulatory inspection preparedness planning for regulatory agency visits and inspections while understanding and implementing processes, controls, and methods that align with global health authority regulatory expectations.

+ Preparation, review, and response preparation of global regulatory submissions i.e. BLAs and NDAs and other technical communications.

+ Excellent verbal and written communication, presentation and interpersonal skills

+ Progressive people management skills

+ Negotiation skills

+ Demonstrable analytical and systematic problem-solving skills

+ Strong influencing skills

+ Business acumen

+ Proven financial management skills

+ Risk management skills

+ Strategy development

+ Ability to effectively manage complex projects across multiple discipline

+ Focus on Customers and Patients

+ Collaborate

+ Act with Candor and Courage

+ Make Rapid, Disciplined Decisions

+ Drive Results

+ Build Talent

+ Demonstrate Ethics and Integrity

Preferred Experience and Skills:

+ Operations experience in the manufacturing of potent drug substance and/or sterile drug products, at pilot and/or commercial scale.

+ Experience with commercialization of ADC programs through PPQ and launch

+ Working knowledge in analytical methods and product attributes for ADCs

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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 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”.

**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/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Antibody Therapeutics, Best Practices Research, Business, Business Case Development, Change Agility, Change Management, Consulting, Engineering Principle, Engineering Standards, Estimation and Planning, Financial Management, Lean Six Sigma Continuous Improvement, Maintenance Supervision, Management Process, Manufacturing Scale-Up, New Product Development, New Product Introduction Process, People Leadership, People Performance Management, Process Architecture, Process Engineering, Process Improvements, Process Technologies {+ 5 more}

Preferred Skills:

Job Posting End Date:

06/19/2025

*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.

**Requisition ID:** R349641