Director Sterile Liquids Commercialization, Manufacturing Division

Job Description

Our company in the United States, Canada & Puerto Rico. We are known in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants, and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.

In a world of rapid innovation, we seek to be joined by driven and adaptable colleagues passionate to make an impact enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit, and diverse perspective to our organization. Together we will continue Inventing for Life, Impacting Lives while Inspiring Your Career Growth.

We seek people-oriented leaders with strong scientific and technical skills to lead the modern design, development, and manufacturing of Sterile Products, making accessible our company's next generation of injectable Vaccines and Biologics.

Part of our company's Manufacturing Division, the Sterile Drug Product Commercialization (SDPC) is involved in Vaccines, Biologics, and Sterile Pharmaceutical product design, qualification, and transfer to clinical and commercial manufacturing sites. It generates product and process knowledge required for approval, launch, and life cycle management of our company's sterile drug products portfolio.

The Director of Sterile Drug Product Commercialization is a technical leader, reporting into the Executive Director of SDPC. Accountabilities and Responsibilities for this position include but are not limited to the following:

• Executes and provides oversight to Vaccines and Biologics sterile product and process design, development, characterization, technology transfer, and robust commercial validation. the expectation is that this role will have a vaccines pipeline focus.
• Manages a group of 6-30 scientists and engineers responsible for the scientific studies execution. Attracts and develops new talent. Provides mentorship, technical oversight, and strategic guidance to employees.
• Is accountable for the performance of 2-6 project teams and the enhancement of a group's technical capabilities.
• Leads the agile implementation of new/improved business processes in partnership with colleagues in our company Research Laboratories and our company's Manufacturing Division.
• Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost. Monitors performance and recommends schedule changes, cost adjustments, or resource additions.
• Organizes activities across programs to suitably forecast and grow the group's laboratory assets.
• Actively seeks cutting edge technologies in manufacturing and testing of vaccines and immune-oncology products, develops collaborations with internal and external networks.
• Drive continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
• Applies expertise in sterile drug product/process realization across programs
• Creates the best and next practices in scale down, parameter finding, unit operation characterization and transfer.
• Uses advanced experience gained on scientific/technical issues to guide others to address non-routine and/or difficult issues.
• Reallocates resources within and between projects to optimize business results
• Supports due diligence and business development opportunities
• Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity, and inclusion

Qualifications

Education:

• Doctorate degree in Applied Sciences, Engineering or related discipline and 6 or more years of directly related experience in vaccines, biologics or advanced therapy-based companies
• Master's degree in Applied Sciences, Engineering or related discipline and 8 or more years of directly related experience in vaccines, biologics or advanced therapy-based companies
• Bachelor's degree in Applied Sciences, Engineering or related discipline and 10 or more years of directly related experience in vaccines, biologics or advanced therapy-based companies

Preferred Expertise:

• Experience with the manufacturing of sterile drug products (vaccines, biologics) at the pilot or commercial scale.
• Working knowledge of cGMPs for manufacturing of sterile dosage forms and current ICH Quality norms as applied in Manufacturing Science and Technology or Technical Operations.
• Experience with Digitalization, Industry 4.0, Data Analytics applications
• Experience with the utilization of QbD principles to process development and life cycle management
• Experience in the Design of Experiment (DoE) and statistical data analysis.
• Experience in authoring and reviewing CMC regulatory documentation.
• Financial acumen, experience with forecasting and budgeting of resources

Must be able to travel for this position (average 25%)

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, 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.

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

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, generally Tuesday, Wednesday and either Monday or 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".

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.

Job Posting End Date:08/27/2024

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:R308057