Why Patients Need You

As a Senior Scientist, provides expert support for Drug Product Manufacturing Technologies (DPMT) and Operations. You will be a member of DPMT team supporting the development and launching of innovative drug products for fulfillment of patient needs.  

What You Will Achieve

Provides technical support to Drug Product Manufacturing Technologies (DPMT) with special focus on liquid and semisolid dosage forms. Develops and validates manufacturing processes for drug products, including new or revised dosage forms or presentations. Leading tech transfer, scale-up activities, and late-stage drug product operations. Conducts tests and measurements throughout the stages of production to determine control over applicable variables. Identifies and implements process and equipment efficiency, safety, quality and/or cost improvements. Supports Quality and Operations with investigation of deviations. Identifies and mitigates risks in development, validation, production, quality, and support operations that could negatively impact the safety, identity, strength, purity, and quality of the product. Performs root-cause analysis and identifies appropriate, effective corrective and preventive actions. Implements corrective and preventive actions in conjunction with other enabling groups (i.e. Engineering, Maintenance, Quality, Validation, EHS). Works comfortably and interchangeably on the manufacturing floor, in lab, and/or office environments

How You Will Achieve It

• Applies extensive technical and industry-specific expertise and has full knowledge of the requirements of other related disciplines (technical, regulatory, QO, project management, etc).

• Leads quality and technical discussions with R&D, regulatory, operations, engineering, and quality teams regarding resolution of compliance related situations.

• Through experience in developing the finished product, process procedures and packaging of liquids, lotions, semisolids, emulsions, suspensions.

• Experience in CPP(s) and CQA(s) assignments for drug product manufacturing process.

• Demonstrated skills in leading, planning, and developing successful technology development and implementation. 

• Technical lead for product/process technology transfer from research, other sites, other areas with the site production

• Perform impact assessments for process deviations, material evaluations and provide justifications

• Perform root cause analysis and identify appropriate Corrective Actions and Preventive Actions

• Ability to gather, analyze, interpret, relate, and compare information from multiple sources and identify cause and effect relationships

• Implements new methods and processes to solve process related problems as assigned and identify and recommending their own work or projects.  Able to adapt and respond positively to situations and people to meet changing work unit priorities

• Design and execute Quality by Design (QbD) and Design of Experiment (DOE) principles in drug product and process development

• Support process validation of new products and tech transfer projects. Create and/or review batch records, recipes and BOM(s)

• Primary author for reports, technical memo(s), process performance qualifications protocols presentations, reports, and technical papers with minimal direction.

Qualifications

Must-Have

• Applicant must have HS Diploma with eight years of relevant experience;

• OR an Associate's degree with six years of experience;

• OR a Bachelor’s degree with at least three years of experience;

• OR a Master’s degree with more than one year of experience.  

• Strong aptitude for learning process technology and equipment.

• Excellent written and oral communication skills.

• Demonstrated ability to interact effectively with all levels of the organization including diverse educational and cultural backgrounds.

• Flexibility and ability to embrace and lead chance.

• Ability to work in a high-paced team environment.

Nice-to-Have

• Experience in a cGMP environment including specific knowledge of and experience with drug product processing and equipment is desired.

• Good understanding of QbD approach and DOE designs

• Experience in regulatory dossier submissions and response to queries

• Through knowledge on validation practices and experience in manufacturing process verifications

• UpToDate with new technologies and applying these techniques and methods where appropriate

Physical/Mental Requirements

• Frequent time in manufacturing, lab, and office environments.

• Must be able to perform gowning requirements for entry in the manufacturing areas.

• Requires lifting, sitting, standing, walking, stair climbing and roof access.

• WORK ENVIRONMENT

• Office environment, with frequent time in the lab/manufacturing areas.

• Possible exposure to high noise environments, solvents, and pharmaceutical ingredients.

• Use of hearing and eye protection is required.

• Must be available to support 24/7 – 365 operation.

Non Standard Work Schedule, Travel, or Environment Requirements

The focus of the work is at the Kalamazoo, MI site, however 0-20% travel may be required for network support.

Work Location Assignment: On Premise

Other Job Details

• Eligible for Relocation Package: YES

Relocation assistance may be available based on business needs and/or eligibility.