Rebekah L. Farnsworth
Summerville,SC
Summary
Dynamic manufacturing leader with extensive experience at Alder Biopharmaceuticals, driving process improvements and ensuring cGMP compliance. Proven expertise in regulatory interactions and team development, fostering collaboration with CMOs. Successfully authored CMC sections for IND and BLA submissions, enhancing product quality and operational efficiency.
Overview
30
30
years of professional experience
Work History
Manager
Alcami
North Charleston, South Carolina
09.2024 - Current
- Led cross-functional teams to streamline operational processes and enhance efficiency.
- Managed project timelines and resource allocation for multiple ongoing initiatives.
- Oversaw compliance with regulatory standards in pharmaceutical manufacturing operations.
- Developed training programs to improve staff skills and operational knowledge.
- Coordinated risk assessments to identify potential issues in production workflows.
- Implemented quality control measures to ensure product integrity and safety standards.
- Fostered a collaborative environment by facilitating team meetings and discussions.
- Analyzed performance data to identify areas for process improvement and optimization.
- Monitored staff performance and addressed issues.
- Coached, mentored and trained team members in order to improve their job performance.
- Completed thorough opening, closing, and shift change functions to maintain operational standards each day.
- Trained employees on additional job positions to maintain coverage of roles.
- Provided leadership during times of organizational change or crisis situations.
- Assigned tasks to associates to fit skill levels and maximize team performance.
- Maintained up-to-date records of employee attendance, payroll information, vacation requests.
- Ensured compliance with all applicable laws, regulations, industry standards.
- Recruited and hired qualified candidates to fill open positions.
- Conducted regular meetings with staff to discuss progress and identify areas of improvement.
- Assessed team member's skillsets and assigned tasks accordingly for optimal efficiency.
- Resolved conflicts between employees by providing guidance on company policies and procedures.
- Led team meetings and one-on-one coaching sessions to continuously improve performance.
- Enhanced team morale and retention through recognition programs and career development opportunities.
- Conducted performance evaluations, providing feedback and coaching for team development.
- Implemented process improvements, resultingin an increase in operational efficiency.
- Conducted performance reviews for team members.
- Ensured compliance with industry regulations and company policies.
- Delegated work to staff, setting priorities and goals.
- Remained calm and professional in stressful circumstances and effectively diffused tense situations.
- Provided leadership, insight and mentoring to newly hired employees to supply knowledge of various company programs.
- Reviewed completed work to verify consistency, quality, and conformance.
- Evaluated individual and team business performance and identified opportunities for improvement.
Director, Manufacturing
Alder Biopharmaceuticals Inc.
01.2018 - 12.2023
- Reporting to SVP Pharmaceutical Operations
- Four direct reports covering upstream, downstream, fill-finish & process trending
- Author and managed technology transfer for Phase I - III and commercial process
- Author and review validation protocols, test execution, configuration documentation, and system release
- Lead CQV throughout lifecycle.
- Author, review, and execution of related CQV documentation.
- Authored, reviewed, and approved CMC sections for IND and BLA submissions.
- Responsible for identifying and implementing process improvements to improve quality, quantity, and reproducibility while cutting costs.
- Established and led manufacturing operations for all Alder programs to ensure cGMP compliance and quality requirements for all deliverables.
- Provided manufacturing leadership and management to ensure the company's success.
- Subject matter expert for manufacturing equipment, as well as manufacturing processes such as fermentation, clarification, downstream purification, and aseptic fills.
- Author and execute development plans for manufacturing staff, promoting a culture of individual and team accountability, and teamwork.
- Assigned manufacturing goals, objectives, and key performance metrics.
- Mentored and trained Manufacturing personnel in change management and deviation assessment techniques to ensure prompt project completion and batch disposition.
- Extensive experience in process monitoring to ensure product quality and ongoing process validation.
- Consistently and enthusiastically cultivate relationships with Contract Manufacturing Organizations (CMOs) to foster a collaborative teamwork atmosphere, contributing significantly to the overall success of each project.
- Purchased by Lundbeck in 2019
Commercial Manufacturing Manger
ICOS corporation
01.2008 - 12.2023
- Reporting to Director of Manufacturing
- Eleven direct reports covering compounding and fill-finish
- Develop information and produce reports concerning scheduling, production goals, equipment and maintenance problems as required.
- Provide manufacturing information by compiling, initiating, sorting, and analyzing production related records and data to key stakeholders
- Ensure all manufacturing discrepancies are captured and appropriately documented
- Develop and retain high performing team to meet current and evolving needs
Manager, Technology Transfer & Scale-up
Trubion Biopharmaceuticals
01.2006 - 12.2008
- Reporting to Sr Director of Process Development
- Technology transfer and scale-up for Phase I CHO process
- Oversight for Phase I clinical manufacturing for CHO process
- Author and approver for manufacturing batch records and Standard operating procedures
- Quality Audits for testing and manufacturing facilities
Manager, Technology Transfer & Scale-up
ICOS Corporation
01.2004 - 12.2006
- Lead transfer of processes from Client organizations into ICOS for clinical manufacturing
- Author and approve all cGMP documentation required for contract manufacturing at ICOS.
- Identify and evaluate new raw material requirements for manufacturing.
- Experience with CHO, yeast and E. coli
Manufacturing Supervisor
CellPro, Inc
01.1996 - 12.2000
- Upstream and downstream manufacturing for Phase II - III and commercial product
- Assisted in the validation of facility/equipment and process before commercialization.
- Author and approver for manufacturing batch records and Standard operating procedures
- Assisted in FDA approval process for facility and product.
Education
Some College (No Degree) - Science
Shoreline Community College
Seattle, WASkills
- Regulatory interactions
- Standard Operating Procedures
- Deviation assessments
- CAPA
- Change Controls
- Teamwork
- Deadline management
- Prioritization
- CMC sections authoring
- IND submission
- BLA submission
- Commercial process validation
- Due diligence
- Process development
- Process evaluation
- Detail-oriented
- Accuracy-centered
- Contract Manufacturing Organizations
Leadership Experience
With over 15 years of experience in a management position, leading teams through Phase I to III, validation, and commercial approval. I have a proven track record of successfully scaling up and performing technology transfer for Drug Substance and Drug Product at multiple facilities.
Timeline
Manager
Alcami
09.2024 - Current
Director, Manufacturing
Alder Biopharmaceuticals Inc.
01.2018 - 12.2023
Commercial Manufacturing Manger
ICOS corporation
01.2008 - 12.2023
Manager, Technology Transfer & Scale-up
Trubion Biopharmaceuticals
01.2006 - 12.2008
Manager, Technology Transfer & Scale-up
ICOS Corporation
01.2004 - 12.2006
Manufacturing Supervisor
CellPro, Inc
01.1996 - 12.2000
Some College (No Degree) - Science
Shoreline Community College