We are currently seeking an exceptional individual for a technical leadership position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization located primarily at either the West Point or Rahway, sites in the US (or alternative listed lab locations in US). The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from API and Drug Product analytical technology transfer and troubleshooting to driving lead time reduction and efficiency gains in support of our company's World Class Supplier (WCS) and Operationalizing Quality goals.
The incumbent will be expected to interact closely with both internal and external sites in the Manufacturing network in identifying, developing, implementing, and troubleshooting laboratory test methods, technologies and workflows as well as material for ensuring compliant, robust, and responsive product supply. The individual will have a deep understanding of the technical, regulatory and business environment needs related to drug product development/commercialization, drug product commercial supply, stability testing and provide critical analytical support to ensure our company's success. The individual will also be responsible for technical training of staff, as needed, on analytical techniques and problem solving. In addition, the incumbent will keep up with drug product related regulatory changes to help influence and facilitate execution of product strategies across the our network. A strong technical background with a superior problem solving skill set, exceptional leadership abilities, strong knowledge of cGMP and Data Integrity are considered essential, as these will be key attributes necessary to facilitate the ability to influence change in efforts to realize our company's WCS vision.
Responsibilities Include :
- Lead and/or execute analytical method development, improvement, validation and/or transfer activities
- Author analytical procedures and/or methods development and validation protocols, technical reports, experimental designs, regulatory submission documents, etc.
- Lead and/or perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
- Provide documentation/technical input during inspections and audits (Regulatory and Internal).
Education Minimum Requirement:
- Ph.D. degree with 3+ years relevant work experience or;
- BS/MS degree with 8+ years of pharmaceutical experience API and/or drug product.
Required Experience and Skills
- Hands on experience working in an analytical laboratory
- Working knowledge of Drug Product development and commercialization and understand the needs related to commercial quality control.
- Working knowledge of developing various analytical techniques (e.g., chromatography, dissolution, spectroscopy).
- Demonstrated strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
- Demonstrated strong interpersonal skills with flexibility and sensitivity in dealing with different cultures
- Demonstrated self-motivation to take ownership and accountability of issues and drive them to completion.
- Ability to speak up and raise issues and help to drive to resolution.
- Ability to quickly adapt to changes and develop appropriate plans for managing risks.
- Working knowledge of lab quality, compliance and data integrity requirements and related recent industry trends
Preferred Experience and Skills:
- Commercial Supply experience.
- Working knowledge of process by which the products are brought to market with an understanding of the roles and responsibilities of the related functional organizations within our manufacturing and research divisions.
- Working knowledge of product specification to support drug development and registration.
- Working knowledge of Chemistry Manufacturing & Control (CMC) filing requirements.
- Experience working with Contract Manufacturing Organization (CMO)'s and Contract Research Organization (CRO)'s
- Experience identifying, implementing and/or sustaining with new lab technologies such as automation, rapid tests, etc.
- Experience participating in regulatory inspections and quality audits.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.
Flexible Work Arrangements:
1st - Day
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Number of Openings:
Requisition ID: R68270