Associate Director, Engineering Bio Technology Solutions

Job Description Welcome to our team:
The Associate Director, Engineering BTS will work within the Site Support (SS) team in the Bio Technology Solutions (BTS) department. The Associate Director will provide management to 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-SS team is also responsible for supporting the BTS Process Development (PD) team during new process/product introductions. Within a multidisciplinary environment you will cooperate with your colleagues from BTS-SS, BTS-PD, BTS-Analytical, Operations, Engineering, Quality Control/Assurance, Supply Chain or Planning, Regulatory Affairs, Safety, and Research. Your main field of attention is to provide all-round technical support to Vaccine and Biopharmaceutical Manufacturing for commercial Animal Health products. Job Description :
Play a critical role in ensuring managing and leading a team with focus on process improvements
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 a team member 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 United States Department of Agriculture 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 our Company 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
#EBRG 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.
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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:
Regular Relocation:
Domestic VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Not Applicable Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
N/A Requisition ID: R287532