Associate Director, Engineering

Job Description

Welcome to our team:

Our Animal Health Manufacturing teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local/regional plants connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.

The focus of an Associate Director within the Site Support (SS) team in the Bio Technology Solutions (BTS) department is on management of a team of scientists and/or engineers, Vaccine and Biopharmaceutical process improvement/troubleshooting in support of commercial antigen/antibody manufacturing and sterile biopharmaceutical product fill-finish, and Technology Transfer. The BTS team is also responsible for supporting the BTS Process Development (PD) team during new process/product introductions. Within a multidisciplinary environment you will collaborate with your colleagues from BTS-PD, BTS-Analytical, Operations, Engineering, Quality Control/Assurance, Supply Chain, Planning, Regulatory Affairs, Safety, and Research. You will also collaborate with team members located at other sites across the globe. Your main field of attention is to provide all-around technical support to Vaccine and Biopharmaceutical Manufacturing for commercial Animal Health products.

Job Description:

• Play a critical role in managing and leading a team with focus on Industry Leading Cost of Goods and process robustness.
• Leads and/or works independently to optimize and/or troubleshoot manufacturing processes for microbial, virus or cell cultures followed by purification/concentration and blending/fill of veterinary vaccines and biopharmaceuticals (antibody therapeutics).
• Leads and/or works independently and/or supports team members with focus on technology transfer within or between manufacturing sites.
• Works at the speed of business to resolve manufacturing challenges while always ensuring timelines meet the requirements of the customer with regard to safety, quality, cost-efficiency, practical applicability, and consistency.
• Leads and/or works independently as a team member on technical investigations, validation and/or process improvement projects.
• Examines issues from diverse perspectives (safety, compliance, automation, equipment, process and people) in order to best understand and resolve the root cause.
• Whether working independently or in collaboration with other departments (e.g. Quality, Research, Production, Bio Technology Solutions - Analytical and /or Process Development), must ensure sound scientific data/literature/evaluation and integrity drives every decision/recommendation.
• If necessary, performs development, introduction and/or testing of new technologies.
• Collaborates and interfaces with Research, Process/Analytical Development, Manufacturing and other departments to ensure commercial products are produced to keep up with commercial needs.
• Demonstrates working knowledge of current regulatory guidelines.
• Develops project charters and project plans and align with all sponsors and stakeholders.
• Key capabilities include project management skills: development of timelines, use of project tracking tools, definition of deliverables, definition of roles and responsibilities, risk identification/tracking/mitigation and business acumen.
• Coordinates and tracks team activities by leading or participating in core team meetings, communicates project risks and status to appropriate stakeholders, and escalates challenges as well as opportunities to sponsors at the speed of the business need.
• Assures consistent application of standardized work, engineering controls, and process analytical technology.
• Authors experimental protocols and reports in support of laboratory or production scale evaluations.
• Creates and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
• Displays leadership behaviors and demonstrate a high emotional intelligence.
• Effectively collaborates with peers on site and above site as required.
• Contributes to international projects (Global Projects). Interacts closely with fellow scientists from your own and other departments. If required with external collaboration partners.
• Actively contributes to the improvement or acceleration of activities within the department, and also within support fields such as Environment Health and Safety.
• Trains and guides other employees and / or interns.
• Performs off-shift work (only as needed).

Education Minimum Requirement:

• Bachelor of Science in Chemical Engineering, Biotechnology, Mechanical Engineering, Biochemistry, Protein Chemistry, or related field with at least 8 years of experience in vaccine and/or biopharmaceutical Development, Process/Product Development through Validation, Management, Technology Transfer, Biopharmaceutical large scale Lyophilization, and/or Biological manufacturing or closely related field.
• Or Master of Science degree and at least 6 years of experience. Or a Doctoral degree with at least 3 years of experience.

Required Experience and Skills:

• Excellent team leadership skills
• Excellent written and oral communication
• Excellent project management, documentation, and writing
• Excellent teamworking and collaboration
• Embraces diversity and promotes inclusion
• Strong problem-solving skills and a hands-on approach to solving problems inclusive of diverse perspectives (e.g. safety, compliance)
• Can work together in multidisciplinary and international teams
• FMEAs
• Technology Transfer Leadership
• Cell Culture and Fermentation
• Experience in bioprocess development, scale up, validation and process improvements
• Experience leading change control
• Working knowledge of USDA regulations, or FDA pharmaceutical regulations
• Knowledge of GMP requirements for manufacture and testing for sterile/parenteral animal and/or human vaccines and biopharmaceutical products
• Understanding of statistics and application to process monitoring and control
• Knowledge management skills and excellent technical writing

Preferred Experience and Skills:

• Lyophilization
• Process Validation
• Regulatory Affairs
• Minimum 3 years direct leadership role

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.

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, 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:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
Yes

Job Posting End Date:
10/22/2024
*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:R316447

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.