[Close] 

Senior Specialist

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that?s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company ? one that is ready to help create a healthier future for all of us.
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 Merck?s campus in Elkton, Virginia, we currently have an opening for a Senior Specialist in our Biologics Process Development group within our Technical Operations team. The manufacturing facility is located in the 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 Upstream Process Development Senior Specialist will be responsible for driving the development, optimization and characterization of current and future fermentation processes at the laboratory scale.
The individual should display strong technical knowledge and scientific understanding of fermentation, harvest, media development, and DOE studies, as well as having experience in process development with both small and pilot scale process scales for biologics development. The individual will lead multiple projects and is expected to provide significant scientific and technical contributions within the Process Development Group and will work closely with other Departments to develop strong working relationships.
Responsibilities include:
+ Strain Development and Expression Optimization
+ Provide hands-on capabilities and technical expertise at bench-scale with a focus on the development of robust fermentation processes.
+ Oversee creation of research and GMP cell banking efforts.
+ Upstream Process Development:
+ Provide technical expertise and support process development efforts aimed at the generation of optimized processes that lead to sustained manufacturing consistency, robustness, scalability, increased efficiency and reduced costs.
+ Quality/Regulatory:
+ Prepare technical reports in support of planned regulatory submissions and future process development work.
+ Support successful preparation of CMC sections of regulatory submissions, as required and serve as a subject matter expert during site inspections.
Education Minimum Requirement:
+ B.S. degree in microbiology, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of 6 years of relevant industrial experience
+ M.S. degree in microbiology, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of 4 years of relevant industrial experience
+ Ph.D. in microbiology, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of 2 years post doctorate industrial experience
Required Experience and Skills:
+ Experience in upstream process development of bacterial cultures and upstream purification of biological products (homogenization, centrifugation).
+ Experience monitoring the performance of laboratory processes and equipment (ex. DeltaV).
+ 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 both downstream and analytical partners.
+ 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:
+ Strong background in microbiology.
+ Experience in yeast cultures
+ Biologics or vaccine processing
+ Sterile processing
+ Project Management
+ Leadership roles
+ Participation in regulatory agency inspections
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we?re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we?re inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
EEOC GINA Supplement? at http://www1.eeoc.gov/employers/upload/eeoc_gina_supplement.pdf
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.
Job _Process Engineering_
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of its manifestations.
Title: _Senior Specialist_
Primary Location: NA-US-VA-Elkton
Requisition ID: _PRO017278_


Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.