Manager, Biomed Operations

I. STATEMENT OF PURPOSE

Responsible for performance and operations of all BioLab activities functions for LCI. Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance.

Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products.

II. RESPONSIBILITY FOR WORK OF OTHERS

Yes.

III. BUSINESS COMMUNICATION

Excellent communication and computer skills required. Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations.

IV. SUPERVISION REQUIRED

Limited supervision.

V. EDUCATION REQUIRED

Bachelor's Degree in Biomanufacturing (BTEC).

VI. TRAINING AND SPECIALIZED KNOWLEDGE REQUIRED

• In-depth knowledge of medical device manufacturing industry regulatory requirements.

• High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, validation and an ability to assess risk and develop solutions.

• Exercise strong risk-based business judgment.

• Manage collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization.

• Build and manage relationships with business partners.

• Prioritize and align the organization with goals and objectives, and ensure rigor in operational excellence.

• Excellent interpersonal, communication, training and presentation skills.

• Demonstrated ability to work with high integrity and an unwavering commitment to our corporate core values.

• Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally

• Extensive investigation and monitoring skills.

• Current knowledge of QC testing methods.

• Attention to detail and implementation of good documentation and GMP processes is essential.

VII. EXPERIENCE REQUIRED

5 years of Biomanufacturing experience, including strong interpersonal skills, a flexible, collaborative and team-oriented approach to problem solving and an ability to work in a fast-paced, rapidly changing environment. Experience in working with and managing third-party contract manufacturers, laboratories, and packagers.

VIII. TRAVEL REQUIRED

Minimal.

IX. SPECIFIC DUTIES AND RESPONSIBILITIES

• Batch Review and disposition:

• Oversee third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches.

• Review and approve Master Batch Records.

• Manage the review of records and determine disposition of:

• Bulk Medical Device Manufactured materials.

• Bulk Medical Device Product and related materials.

• Packaged/Labeled Medical Device Product.

• Clinical Product

• Investigations and CAPAs.

• Review and approval of Change Controls.

• Review of Laboratory Methods and Validation Reports.

• Manage the review of Testing Specifications.

• Validation

• Coordinate and monitor validation activities.

• Develop and enhance LCI policies and procedures related to BioMed Operations.

• Responsible for support during regulatory inspections of GMP Contractors and LCI facilities.

• Oversee inspection readiness activities.

• Review Quality Agreements.

• Review CMC submissions.

• Maintain current understanding of laws & regulations applicable to the medical device manufacturing and biotechnology industry.

• Participate on cross functional teams, as needed.

• Provide updates to Director, Technical Services.

• Participate in the selection and manage utilization of LCI and contracted employees performing duties related to the Batch Record Review, Disposition, and Validation function.

X. PHYSICAL DEMANDS

While performing the duties of this job, the employee is in a moderate office environment. The employee is regularly required to sit; stand; walk and use hands.

XI. WORK ENVIRONMENT

The noise level in the work environment is usually moderate. When in the Manufacturing area, hearing protection may be required depending on the department.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.