Process Development Engineering Specialist

Job Description

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and consumer health products, as well as animal health products.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

At our Company's campus in Elkton, Virginia, we currently have opening for two Specialist positions in our Process Development group. The facility is located in the beautiful Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains a short distance from the University of Virginia and James Madison University.

A successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of pharmaceutical, biopharmaceutical, vaccine product manufacturing facilities. More specifically, the Process Development Specialist will participate in driving the development, optimization and characterization of current and future fermentation and purification processes at the laboratory and pilot scales. They will also have the opportunity to work closely with commercial manufacturing to help with technology transfers and process troubleshooting.

The candidate should have strong experience with biochemical laboratory tools and techniques used for production, and purification of recombinant proteins, process optimization and analytical methods. The individual should also be able independently and proactively execute procedures and experimental objectives in a timely and detail-oriented manner. The ability to learn quickly and work in a fast-paced matrix-team environment is desirable. Additional responsibilities include good documentation practices and maintaining an electronic laboratory notebook and adhering to strong safety culture.

Position Qualifications:

Education Minimum Requirement:

• B.S. degree in biochemistry or microbiology or biochemical engineering or biological systems engineering or biology or chemistry or related life science or engineering discipline and a minimum of 4 years of relevant industrial or academic experience.

OR

• M.S. degree in microbiology, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of 2 years of relevant industrial or academic experience

OR

• Ph.D. in biochemistry, biochemical engineering, biological systems engineering, biology, chemistry or related life science or engineering discipline.

Required Experience and Skills:

• Hands-on laboratory and pilot scale experience on large molecules including but not limited to biologics and vaccines.
• Experience with multiple modes of recombinant protein production, purification, and analytical methods.
• Strong problem-solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field.
• Ability to work independently and within a team collaborating with multiple partner teams.
• Strong attention to detail.
• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.
• Enthusiasm, confidence, and initiative-taking ability needed for continuous learning and its applications.
• A strong desire to succeed and to help others to do the same.

Preferred Experience and Skills:

• Process development experience on multiple biologics and vaccine modalities at laboratory and pilot scale.
• Experience using laboratory and pilot scale equipment including but not limited to Chromatography and Tangential Flow Filtration equipment such as AKTA Purification Systems, Tecan systems, any other purification or high-throughput systems used for protein purification.
• Experience working with Waters/Empower platform for both HPLC and UPLC.
• Experience with bio-analytical methods including but not limited to electrophoresis, CE, ELISA, PCR, CIEF etc.
• Experience working in a GLP/GMP environment is a plus.
• Able to have a flexible work schedule – occasional shift work or odd hours to support the laboratory studies.
• Experience with Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions.
• Excellent organization skills to manage multiple projects or assignments.
• Experience trouble shooting technical issues (experimental, instrument-related issues etc.).
• Experience in process development and technical transfer.
• Excellent written and verbal communication skills.
• Participation in regulatory agency inspections.
• Strong preference to safety culture.

NOTICEFORINTERNALAPPLICANTS

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:

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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.

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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:08/24/2024

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:R308353