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- Associate Director, Sterile Operations - Aseptic Processing
Associate Director, Sterile Operations - Aseptic ProcessingBookmark This
Posted: November 15 2016
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This position will provide technical and strategic stewardship, mentorship, and oversight of Sterile Operations and Aseptic Processing at the Akorn India Manufacturing site. The role involves use of risk-based approaches to define and assess aseptic and process controls for existing processes and new installations. Responsibilities will include developing and implementing targeted process improvements, as well as strategic-level transformations to the site’s sterile operations. Oversight will include the integrated aspects of aseptic processing including: aseptic process simulations, aseptic manipulation / intervention programs, sterility assurance risk assessment strategies, providing strong scientific leadership for all aspects of process scale-up, process monitoring, and process troubleshooting This position will lead and integrate initiatives that drive the highest sterile operating standards across multiple functions. This position ensures alignment with evolving corporate and global aseptic standards, quality system element remediation, regulatory inspection information, external benchmarking and best practices resulting in robust inspection readiness and alignment.
· Direct the development, planning, implementation and maintenance of aseptic processes and sterile operations.
· Develop strategies and actions to continuously improve data management practices assuring inspection readiness.
· Assess and enhance site level SOPs and corporate level policy documents
· Work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, root cause analysis and risk assessment.
· Serve as the Corporate SME for Sterility Assurance.
· In collaboration with the Senior Director participates in strategic initiatives and corporate activities to include quality system re-deployment, site level remediation.
· Collaborate with senior leadership team in meeting corporate goals.
· Provide guidance and leadership to support operations in compiling and analyzing production data, such as IPC, release, and manufacturing process information.
· Author pertinent SOP's and manufacturing process instructions.
· Provide leadership in the preparation of Change Controls, investigations, and CAPAs
· Provides guidance and leadership on ISO11135 and ISO11137, by working with site staff to design and validate sterilization cycles for new products.
• PhD degree (preferred) in Microbiology or other relevant Life Science discipline with a minimum of 10+ year pharmaceutical/biotech experience, or a BS with 15+ years or an MS with 12+ years of pharmaceutical/biotech experienced based on the required skill set.
• 75% International Travel Required.
• Prior experiences in managing microbiology and aseptic manufacturing processes are preferred.
· Thorough knowledge of contamination control, disinfection, microbiology, sterility assurance, aseptic processing, and regulatory requirements.
· Experience in project management.
· Working Knowledge of applicable cGMP regulations (21CFR 211, EU GMP, PIC/s GMP, USP,EP, ICH)
· Computer skills with utilization of Microsoft Office (Outlook, Word, and Excel) are required.
· Effective time management and organizational skills
· Strong attention to detail and cross functional teams experience
· Strong leadership skills, ability to drive accountability, compliance and efficiency throughout the department
· Highly creative, able to conceive and develop ideas to successful laboratory implementation.
• Skilled at team motivation and people development.
· Demonstrated excellent written and verbal communication skills.
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.