Specialist, Engineering (Onsite)

Job Description In our Company's Research Labs, we identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough. Seeking candidates for a unique and exciting opportunity to bridge across two pilot scale facilities in VAX and Biologics Process Research and Development. The Vaccines and Advanced Biotechnologies Process Research & Development (VAXPR D) and Biologics Process Research & Development organizations within our Company Research Labs are broadly responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products This Specialist role will first support the Biologics Pilot Plant (BPP) Operations Team. This person will work on pilot-scale campaigns for the Good Manufacturing Practice (GMP) manufacture of bulk clinical supplies, leading operations on either upstream or downstream steps, and contributing to manufacturing activities in the other discipline as needed. Strong comprehension of regulatory guidelines governing GMP manufacture is essential. The candidate will work in matrixed teams with analytical and tech transfer/process development, facility engineering, quality engineering, GMP compliance, and safety groups. Some overtime, including weekends and occasional second and third shift work, will be required. Assignments include all aspects of preparation, execution, and closeout of a GMP campaign. The position will be temporarily based in West Point, PA for approximately 18 months (up to 24 months) to support business needs. After this period, the role is intended to relocate to Rahway, NJ . Applicants should be comfortable with this planned geographic transition. In Rahway, the position will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

Primary Responsibilities:

• Executing upstream unit operations such as mammalian/yeast/bacterial cell expansion, virus/protein expression in single-use disposable systems and/or stainless-steel bioreactors.
• Performing downstream operations such as normal flow filtration, tangential flow filtration, chromatography, and centrifugation.
• Preparing critical documents including standard operating procedures, batch records.
• Completing production readiness activities such as equipment cleaning & steam sanitization.
• Evaluating and integrating innovative technology/process equipment fit.
• Developing equipment specifications & participating in start-up activities.
• Working in a multi-disciplinary project team environment.
• Troubleshooting process unit operations.
• Leading teams.

This person will lead manufacturing steps and must be able to plan, communicate, and lead small groups to achieve tactical objectives.

Education Minimum Requirements:

• Bachelor's degree in Chemical Engineering or Biological Sciences with 2 full years of relevant experience or a Master's degree with 1+ years of relevant experience.

Required Experience and Skills:

• GMP manufacturing of biologics, or vaccines, and/or process development activities.
• Teamwork and collaboration
• Working knowledge of cGMP, Quality Systems, and safety for operations
• Self-motivated with the ability to work in a fast-paced and dynamic setting

Preferred Experience and Skills:

• Proficient in SAP
• Organizational, problem-solving, and project management skills
• Technical background in one or more process unit operations
• Experience leading small teams in a matrixed organization
• Demonstration of Decision Making, Execution Excellence, and Ownership and Accountability Leadership Skills #eligibleforERP #

PRD Required Skills:

Adaptability, Adaptability, Centrifugation, cGMP Guidelines, Chemical Engineering, Chromatography, Clinical Trials, Cytometry, Cytopathology, Electronic Batch Records, Fast-Paced Environments, GMP Compliance, Laboratory Experiments, Mammalian Cell Culture, Motivation Management, Personal Initiative, Pilot Plant Operations, Process Engineering, Process Optimization, Product Formulation, Protein Expression, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Tangential Flow Filtration (TFF), Teamwork {+ 1 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 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

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 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". The salary range for this role is $87,300.00 - $137,400.00 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 employee's 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 https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (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:

Not Applicable Shift:

1st - Day, 2nd -

Evening Valid Driving License:

No Hazardous Material(s): n/a

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.

Requisition ID:

R395885