Scientist 1 - Analytical Development

Merck Group • $75K — $112K *
Rockville, MD 20850In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Ph.D. in a scientific discipline or relevant Master's/Bachelor's with experience.
  • Experience in analytical method development in a biopharmaceutical setting.
  • Broad knowledge of laboratory practices, techniques, and equipment.
  • Intermediate proficiency in data management software (e.g., Excel, LIMS).
  • Strong oral and written communication skills for cross-functional collaboration.

Responsibilities

  • Lead and develop analytical methods for biotherapeutics and ensure they meet industry standards.
  • Act as a subject matter expert, providing guidance on analytical techniques and protocols.
  • Design experiments to solve complex analytical challenges across various modalities.
  • Prepare and review analytical documentation, including protocols and reports.
  • Conduct laboratory testing to support method development and validation activities.
  • Train other team members on GMP assays and analytical processes.
  • Engage with internal and external stakeholders to ensure project alignment and regulatory compliance.

Benefits

  • Health insurance coverage.
  • Paid time off to encourage work-life balance.
  • Retirement contributions to support future financial security.
  • Opportunity for performance-based bonuses.
Full Job Description
Your Role:

At MilliporeSigma, as a Scientist 1 - Analytical Development, you will be the primary scientific lead for assigned studies within the Analytical Laboratory as part of the Analytical & Bioassay department. This role is responsible for leading analytical method development/validation and feasibility/transfer to support the manufacture of clinical and commercial products. The Scientist will collaborate with cross-functional teams to ensure analytical methods are robust, reliable, standardized, and ready for implementation.

Key Responsibilities:
  • Understand GMP requirements for analytical method validation, transfer and associated documentation.
  • Act as a subject matter expert (SME) for analytical methods and provide technical guidance to analysts, study managers, and cross-functional teams.
  • Apply laboratory techniques and scientific expertise to design and execute experiments that address complex analytical challenges.
  • Design, optimize, and troubleshoot analytical methods for a wide range of modalities, including monoclonal antibodies (mAbs), cell and gene therapy products, antibody-drug conjugates (ADCs), mRNA therapeutics, viral vectors, and other biotherapeutics, ensuring methods are fit-for-purpose and aligned with phase-appropriate regulatory expectations.
  • Lead analytical method development/validation and feasibility/transfer activities, ensuring studies are initiated and completed on schedule.
  • Prepare, review, and approve protocols, reports, SOPs, laboratory records, technical specifications, and other related documents.
  • Execute analytical methods in the lab to support method development/validation and feasibility/transfer.
  • Perform analytical testing in accordance with SOPs and cGMP regulations.
  • Transfer GMP assays to routine team and provide training to analysts, study managers, report writers, and QA.
  • Operate and maintain lab equipment as required by SOPs and testing procedures.
  • Utilize applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc.).
  • Lead general change control and resolve deviations by completing event records.
  • Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes, and equipment.
  • Ensure current regulatory requirements and technical needs of internal and external clients are appropriately met.
  • Maintain strong communication skills to effectively interact with internal and external stakeholders.
  • Participate in client interactions, scientific discussions, and technical presentations as a representative of the Analytical Development team.
  • Perform other duties and responsibilities as assigned.


Who You Are

Minimum Qualifications:
  • Ph.D. in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, etc.)

-OR-
  • Master's Degree in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, etc.), with 3+ years relevant experience

-OR-
  • Bachelor's Degree in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, etc.), with 5+ years industry experience


Preferred Qualifications:
  • Broad working knowledge of the field, with experience in relevant laboratory practices, techniques, equipment, materials, and mathematical calculations.
  • Intermediate skills in applicable computer programs.
  • Experience with analytical method development in a pharmaceutical, biotechnology, or related laboratory environment.
  • Excellent oral and written communication skills demonstrated through technical presentations, project leadership, implementation of new services, and cross-functional collaboration, etc.
  • Excellent time management skills, with the ability to manage multiple priorities effectively.
  • Highly collaborative as well as independent.
  • Demonstrate a high level of initiative, leadership, and problem-solving capabilities.
  • Effective coaching and training skills for complex and highly technical work.
  • Experience with some or all of the following technical disciplines:
    • Liquid Chromatography (HPLC; e.g., SEC, RP, IEX, and residual/impurity testing).
    • Mass Spectrometry (Intact Molecular Weight, Peptide Mapping, Disulfide Mapping, Glycan Profiling, N-/C-Terminal Sequencing).
    • Capillary Electrophoresis Methods (CE-SDS, cIEF).
    • Compendial assays and alternative methods (e.g., container closure integrity-related methods).


Pay Range for this position - $75,000 - $112,000

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

RSREMD

RSREMD

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

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Pharmaceuticals & Biotech
* Ladders Estimates

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