Associate Scientist Engineering - Biologics Process Development and Commercialization

Job Description

Associate Scientist, Process Analytics Lab Lead, Biologics Drug Substance Commercialization

Join Our Team as a Biologics Process Analytics Associate Scientist!

We are seeking a strategic and technical scientist with expertise in process analytics development & commercialization space to support our ever growing and dynamic late-stage biologics pipeline within the expansive Biologics S&T portfolio.

Why You'll Love This Role:

As an Associate Scientist in Biologics Process Analytics Commercialization, you’ll be at the forefront of supporting a rich robust pipeline by delivering analytic insights to process stakeholders.

As the laboratory lead, you will troubleshoot and solve problems for the laboratory and operating systems, applying technical skills to bring in new assays in our non-GMP laboratory. In addition, you will lead a small team with the goals of maintaining a high performing team, with focuses on data integrity, quality and meeting desired turnaround times. You will also work with internal and external partners to provide reliable and efficient laboratory operations. You will engage our program team members to understand their needs and continually look to improve operations by developing efficient solutions that will support business objectives and ensure continuity and Safety, and Environmental compliance.

Key Responsibilities:

• Team Leadership: Lead the day-to-day scoping and prioritization for testing of non-GMP analytical samples, for a team of non-Company employees. Appropriately communicate and delegate to team members to ensure program deliverables are met and resource allocations are managed appropriately
• Lab Operations Leadership: Working closely with lead of non-Company employees, the lab lead will oversee daily lab operations, lab tier, lab preparation, scheduling, training, inventory management, and operational metrics to enable efficient experimental execution and continuous improvement. Lead establishment of new assays and new molecules for the team.
• Reliability and Capability Improvement: Resolve equipment and system issues, reduce downtime and excessive maintenance or energy use, and partner with vendors and internal stakeholders to enable capability enhancements.
• Compliance, Safety, and Process Safety Leadership: Ensure laboratory activities, systems, and equipment are maintained in compliance with safety, environmental, quality, regulatory, and Process Safety Management requirements.
• Cross-Functional Collaboration: Unite diverse teams to achieve program goals as One Team. Collaborate with counterpart in NJ to ensure alignment across teams. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Experience and aptitude to work, and collaborate in internal and external cross-functional, matrixed teams.
• Documentation: Maintain high-quality documentation practices compliant with ALCOA principles. Author and/or review technical documents including development reports, analytical test protocols, laboratory procedures, comparability protocols, etc.
• Communication: Excellent interpersonal and communication skills
• Project Management: Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.
• Recognition: Celebrate team achievements and foster a culture of appreciation.

Education Guideline:

• B.S in Analytical Sciences/ Chemistry/ Chemical Engineering/ Biochemistry or related field

Preferred Skills:·

• Experience with HPLC/UPLC/capillary electrophoresis executions and data analysis of therapeutic proteins using various techniques such as IEX, SEC, HIC.
• Experience with Empower software.
• Leadership skills and ability to manage the daily tasks of a small team of analysts.
• Ability to perform benchtop laboratory operations.
• Demonstrated ability to plan, execute, optimize, and troubleshoot analytical assays.
• Outstanding communication (oral and written), organization and time management skills; ability to work independently and collaboratively.
• Motivation to learn new skills, willingness to take on new challenges, and scientific curiosity.
• Experience in using Power BI, Spotfire, or other data analytical software.
• Ability to work independently and as part of a team, self-motivator, positive attitude, and proactive problem solver.
• Ability to foster a collaborative working environment.
• Adaptability and capability to respond to changing needs.
• Strong attention to detail and quick learner.
• Demonstrate ability and/or aptitude in data processing and advanced data analysis.
• Some knowledge and understanding of pharmaceutical drug substance processing.

Required Skills:

Preferred Skills:

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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. Asa 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:

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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.

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The salary range for this role is

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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