Specialist, Analytical Technical Solutions (ATS)

Job Description

Join our Millsboro Analytical Technical Solutions (ATS) team as a Specialist providing analytical support assisting in the critical production of veterinary large molecule biotherapeutics. This role involves working in regulated and/or non-regulated environment performing and supporting method development, validation and transfer activities from R&D to QC, from external sites or site-to-site. You will work with a variety of analytical methods and technical equipment independently or under moderate supervision, ensuring highest standards of safety and quality. 

Key Responsibilities:

• Develop, validate and transfer of phase-appropriate analytical methods for characterization and release testing of Large Molecule drug substances and drug products.

• Conduct LC and LC-MS based method development for characterization of biologics (may include, charge particle analysis, reduced mass, intact mass, peptide mapping and glycan mapping) to provide better understanding of biologics attributes.

• Interface with collaborators, CROs and CDMOs to facilitate method development, validation and transfer activities.

• Author, review and approve test procedures, protocols, and reports.

• May serve as a SME and aid in investigation of deviations, OOS and OOT analytical results

• Plan, execute, document and data analysis and present results to multidisciplinary team.

• Troubleshoot and maintain lab instruments including but not limited to UPLC, LC-MS, osmometer, nanodrop etc. ensuring they remain in peak operational condition.

Education Requirements:

• Bachelor’s degree in Life Sciences, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field.

Required Experience and Skills:

• Prior biotech experience in analytical method development for large molecules or proteins/monoclonal antibodies preferred.

• Knowledge of method development and characterization of protein therapeutics using various analytical techniques, including liquid chromatography (HPLC/UPLC/FPLC, size exclusion chromatography, LC-MS), SDS-PAGE, Western blot, UV-Vis spectrophotometry, particle size by DLS or equivalent and capillary electrophoresis (CE-SDS).

• Familiarity with regulatory (GMP, USDA, FDA, ICH) guidelines and industry best practices is a plus.

• Understanding of statistical evaluation of analytical data and familiarity in data acquisition using Chromatography Data Systems (CDS) and processing software.

• Ability to multitask and work in a fast-paced environment

• Good attention to detail and ability to thoroughly document experiments, data, technical reports and findings electronically in an accessible manner with good documentation practices.

• Familiarity with standard office software (MS Office, Teams, SharePoint etc.)

• The candidate should be self-motivated, accountable and possess excellent organization skills.

• Ability to follow Global Health, Safety and Environment guidelines while performing routine tasks upholding our company's commitment to “Safety First, Quality Always”.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of Animal Health biopharmaceuticals 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.

Required Skills:

Adaptability, Adaptability, Analytical Chemistry, Aseptic Manufacturing, Bioanalysis, Biochemical Analysis, Biochemical Tests, Biochemistry, Capillary Electrophoresis (CE), cGMP Compliance, Column Chromatography, Data Analysis, Decision Making, Documentation Review, EHS Compliance, FDA Regulations, Immunochemistry, Interpersonal Relationships, Laboratory Operations, Laboratory Quality Control, Liquid Chromatography-Mass Spectrometry (LC-MS), Multitasking, Quality Inspections, Quality Operations, Regulatory Compliance {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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.  As a 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.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$87,300.00 - $137,400.00

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

01/26/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.