SENIOR DRUG PRODUCT MANUFACTURING ASSOCIATE
BOULDER, CO

Hybrid (3 days Onsite).

Project Description:

• Support all aspects of drug product manufacturing operations at CMO's to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations, and schedules.
• Partner with CMOs to accurately review and approve master batch records and executed batch records.
• Support device development and implementation by supporting device engineers and regulatory experts.
• Assist in managing change controls, quality events, investigations as needed.
• Manage key manufacturing metrics / goals, support critical program milestones, and drive continuous improvement initiatives that are essential to meeting patient and business needs.
• Rapidly and accurately communicate issues to Senior Leadership. Resolve manufacturing and facility issues to mitigate any supply disruptions to our patients.
• Work effectively across all departments, such as Quality Assurance, Facilities, Engineering, Program Management, Regulatory, Quality Control, IT, and Supply Chain.
• Oversee and approve schedules, production plans, and material requirements.
• Ensure the effective use of material, equipment, and personnel in producing quality products.

Required Skills:

• MS/PhD in Biochemistry/Microbiology/Chemistry/Engineering or related discipline and 5+ years in a cGMP setting preferred.
• In-depth experience in pharmaceutical operations associated with aseptic processing.
• Demonstrated competence in updating design control documents for design history files.
• Experience with testing support for primary packaging components.
• Experience supporting studies for the EU submission gaps.
• Experience working to standards required for regulatory compliance of Aseptic Processing facilities.
• Understanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities and associated pharmaceutical processes.
• Understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems.
• Ability to perform risk assessments.
• Excellent verbal and written communication skills.
• Ability to work effectively with CMOs and establish and maintain relationships with external suppliers.
• Strong planning & organizational skills (and an ability to work to targets, deadlines, and prioritize).
• Proficient in MS Word, Excel, MS Project & PowerPoint.
• Understanding of national and international regulatory requirements as it relates to Aseptic Manufacturing.
• Proficient in generating and executing protocols and reports.

This 12+month position starts ASAP.

ALPHA'S REQUIREMENT #23-00314
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Job Types: Full-time, Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Work Location: One location

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