The MS&T Process Scientist supports clinical and commercial product manufacturing, technology transfer, and process troubleshooting at the Frederick Manufacturing Center.
Compensation
The annual base pay for this position ranges from $ 112,304 - $168,456 depending on level. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Responsibilities
Lead or participate in molecule support activities such as fit-to-plant, process risk analysis, and batch record review
Serve as Drug Substance process Workstream Lead and/or general Technical Lead for clinical and commercial projects
Mentor and supervise entry-level scientists or associates
Analyze data using multivariate analysis software and present results
Author/review technical reports and deliver presentations
Requirements
BS/BA/MS/PhD in Engineering, Biological/Physical Sciences, or equivalent focus of study
Administers and endorses quality standards to ensure products, services, and processes consistently meet intended purpose and stakeholder expectations.
Compensation
CIL and CIS offer a competitive salary and comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.
Responsibilities
Oversee and maintain assigned processes within the QMS
Conduct root cause analysis for investigations
Assess risk, product, and process assessments
Determine and complete appropriate effectiveness checks
Review quality trends, production data, and recurring issues
Requirements
Bachelor’s degree in chemistry/sciences, quality assurance/management, or equivalent
Operations Specialist supporting shop floor execution, batch closeout, and troubleshooting in a GMP manufacturing environment.
Compensation
The salary range for the primary location of this role is: $79,200.00 - $124,700.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.
Responsibilities
Partnering with the Operations management team to create and execute strategies that support design, development, delivery and evaluation of projects related to steady‑state production and/or continual process improvement.
Authoring and reviewing documents and SOPs.
Batch Record Review.
eLog Review.
Lead safety investigations.
Requirements
High School Diploma
Bachelor’s degree in a technical field
Bachelor's degree in a direct GMP, biotechnology, manufacturing setting
Nice to have: Understanding of MPS methodologies
Nice to have: Experience with shop‑floor cGMP manufacturing and related systems (i.e. SAP)
An energetic individual responsible for supporting shop floor execution, batch closeout, and general troubleshooting.
Compensation
$79,200.00 - $124,700.00
Responsibilities
Partnering with the Operations management team to create and execute strategies that support design, development, delivery and evaluation of projects related to steady-state production and/or continual process improvement.
Authoring and reviewing documents and SOPs
Batch Record Review
eLog Review
Lead safety investigations
Requirements
High School Diploma
Bachelor’s degree in a technical field
Nice to have: Understanding of MPS methodologies
Nice to have: Experience with shop-floor cGMP manufacturing and related systems (i.e. SAP)
Nice to have: Familiarity with pharmaceutical regulatory requirements
The Quality Control Associate provides testing protocols on product components and finished goods, ensuring results meet consumer law, our company standard, and customer requirement, across the three stages of production: before, in-process, and final.
Responsibilities
Maintain calibration of quality control equipment.
Conduct product testing, including testing to support complaint investigations.
Generate product testing results reports.
Review production batch records for accuracy and completeness in order to approve intermediate products for use in production.
Report all deviations and assures these have been addressed and resolved prior to issuing approval.
The role plays a key part in the batch release process, ensuring critical and documented review of manufacturing and control records in compliance with BPF/GMP regulatory requirements.
Responsibilities
Perform the review and release of batches (internal and outsourced products)
Guarantee the compliance of manufacturing and control records
Lead investigations related to deviations, particularly related to environmental monitoring
Evaluate the impact of production deviations and follow up on associated actions (waivers, CCR, CAPA)
Participate in trend analysis and continuous quality process improvement
Requirements
Master's degree in quality, medical devices, pharmaceutical, or equivalent
Nice to have: Experience in pharmaceutical industry
Nice to have: Experience in medical device industry
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