Merck Senior Scientist, Chemistry in Riverside, Pennsylvania
Our Manufacturing Division 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. Our Company is 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 at Rahway, NJ, USA.
The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from API and Drug Product analytical troubleshooting to driving lead-time reduction and efficiency gains and Operationalizing Quality.
The incumbent will be expected to interact closely the external sites (CMO’s) in our Manufacturing network in identifying, implementing, and troubleshooting laboratory test methods and workflows as well as material for ensuring compliant, robust, and responsive supply.
The individual needs to have a solid understanding of the regulatory and business environment related to API development and commercial supply, providing 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 API regulation changes and facilitating central development group to make adjustments to our company's product development strategies.
The position will report into SAS API.
A strong technical background with excellent problem solving skills, solid 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.
Author analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.
Perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
Education Minimum Requirements
BS/BA in Chemistry or related discipline with at least 7 years of relevant pharmaceutical development experience or;
MS in Chemistry or related discipline with at least 5 years of relevant pharmaceutical development experience or;
PhD in Analytical Chemistry or related discipline with 0-3 years of experience.
Required Experience and Skills
Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends.
Have working knowledge of API development and commercialization and understand the needs related to commercial quality control.
Have working knowledge of developing various analytical techniques (e.g., chromatography, and spectroscopy) and product specification to support drug substance development and registration.
Have experience working with CMO’s and CRO’s.
Have working knowledge of CMC filing requirements.
Demonstrate strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures
Self-motivated 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.
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.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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 .
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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.
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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:
Remote Work, Work Week
1st - Day
Valid Driving License:
Yes - common lab chemicals, drug substances and drug products for analytical testing.
Number of Openings:
Requisition ID: R62185
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