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Yyyyyy x. yyyyyy

2424 NW Majestic Ridge Drive Bend, OR 97703 (xxx-xxx-xxxx abc@xyz.com

 

Pharmaceutical Manufacturing Strategic Analysis / Planning Team Building Training / Development

Continuous Process Improvements Facility Audits Multi-Process Optimization Quality Control Quality Assurance

Production Center Management Good Manufacturing Practice Lean Six Sigma Regulatory Compliance Corrective Actions

 

  • Dynamic Pharmaceutical Manufacturing Leader who makes decisions to reflect positively on high-volume production operations in alignment with a company s vision, value, and goals, and who works to attain a competitive advantage and generate robust growth via solutions-centric critical thinking talents for insightful, change-driven results.
  • Top Performer who exhibits skill in developing and implementing processes and procedures to increase productivity and efficiency while maintaining superior compliance and meeting or exceeding client expectations.
  • Visionary Professional who rises above core challenges to improve the bottom line and achieve winning outcomes, including quickly adapting to evolving scenarios to optimize resources and reach high profit and productivity levels, as well as independently resolving in-depth issues among internal and external business parties to boost success.
  • Excellent Communicator who develops synergistic relationships with cross-geographical decision-makers, manufacturing / quality staff, and customers; who excels in fast-paced autonomous and collaborative environments; and who leads peers by example and with integrity to inspire confidence and forge strong teamwork to meet objectives.

 

Professional Synopsis

 

Bend Research, Bend, OR 2015 Present

 

Director of Commercial Manufacturing

  • Capitalize on the opportunity to lead forward-thinking manufacturing initiatives for state-of-the-art production, including directing efforts for approved products to be manufactured on schedule and within quality and cost objectives.
  • Spearhead resourceful collaborations with Quality Control, Product Development, Engineering, and Finance teams to create and grow commercial manufacturing processes, and establish metrics to promote results-driven decision-making.

 

  Increased production output by 125% within a one-year period.

  Successfully increased production standards to exceed manufacturing goals.

  Interfaced with QA teams to re-establish EU certification for GMP manufacturing in one year.

 

Pacira Pharmaceuticals, San Diego, CA 2013 2015

 

Senior Manufacturing Manager

  • Strategically steered bulk production operations for a new Exparel product, including mentoring and managing a manufacturing team; collaborating with Process Development to facilitate seamless process transfer from PD to Manufacturing; and planning all schedules, resource utilizations, and regulatory, safety, and environmental compliance.

 

  Increased production output by 236% across a two-year period.

  Expertly developed and drafted capital and resource requirement plans.

  Reduced cycle time and improved quality via continuous improvement projects.

  Collaborated with QA to successfully re-establish EU certification for GMP manufacturing in one year.

 

Ben Venue Laboratories Boehringer Ingelheim, Bedford, OH 2011 2013

 

Manager Focus Factory (2012 2013)

  • Utilized broad scope of industry knowledge toward coordinating and managing high-volume production centers within the Focus Factory, including Sterile Filling, Lyophilization, Component and Equipment Preparation, Formulations, and Packaging, as well as continually driving site culture in alignment with companywide vision and goals.
  • Contributed sharp analytical abilities toward cost-effectively maintaining expense control of all budgetary items, along with auditing, overseeing, and driving sustainability in 5S and Lean Manufacturing principles in all production areas.
  • Developed and managed systems to measure and monitor large-scale production performance parameters while proactively cultivating a successful work environment that resulted in continuous improvement initiatives.

 

  Consistently met or exceeded production goals and client expectations.

  Communicated the critical importance of a Good Manufacturing Practice (GMP) culture.

  Coordinated delivery of training to ensure staff compliance with SOPs and regulatory requirements.

  Developed and implemented SOPs for continued improvement and manufacturing protocol adherence.

 

Yyyyyy x. yyyyyy

Page Two (xxx-xxx-xxxx abc@xyz.com

 

Professional Synopsis (continued)

 

Ben Venue Laboratories Boehringer Ingelheim, Bedford, OH (continued) 2011 2013

 

Production Lyophilization Supervisor (2011 2012)

  • Drove production initiatives by directing all facets of production lines to achieve on-time, under-budget operations, including leading a team of 12 direct reports, as well as planning and prioritizing workflow in alignment with resources.

 

  Successfully accomplished maximum production levels at all times.

 

Hospira (f/k/a Abbott Laboratories & Sanofi Winthrop), McPherson, KS 2003 2011

 

Contract Manufacturing Analyst (2010 2011)

  • Led targeted decision-making in collaboration with plant operations and third-party customers to produce new products and extensions of existing lines, including educating customers on facility-wide capabilities to meet objectives.
  • Planned and coordinated materials, scheduling, production, quality control, validations, and finance; managed product and process development projects; prepared documentation for production of third-party scale-ups, stability batches, and new products / processes; and reviewed documentation for new drugs and component or process changes.

 

  Managed product release to achieve contract and customer requirements.

  Developed monthly Latest Best Estimates of sales and margins to adhere to plan.

 

Manufacturing Quality Supervisor (2003 2010)

  • Optimized manufacturing quality by enforcing guidelines and regulatory compliance, along with collaborating with managers to support off-shift quality assurance efforts in guaranteeing product integrity, effectiveness, and standards.
  • Led a team of 13 while evaluating, processing, and providing final approval and sign off on regulatory documents.
  • Liaised among FDA and third-party customers during comprehensive manufacturing facility auditing processes.

 

  Enhanced processes and production by authoring SOPs and analyzing quality requirements.

  Recognized for routinely exceeding expectations and working independently to achieve key goals.

 

Abbott Laboratories, McPherson, KS 1999 2003

 

Production Supervisor (2001 2003)

  • Coordinated and led fast-paced production lines to establish and maintain on-time, under-budget operations while mentoring and managing a 50-member team, as well as scheduling and prioritizing workflow to optimize production.

 

  Reduced material and labor discrepancies throughout supervised lines.

  Proactively participated in numerous Plant Safety Committee initiatives.

 

Group Leader (1999 2001)

  • Played a vital role in mentoring and managing a details-driven team of 20 across several departments, including continually coaching staff to exceed goals, as well as conducting objective performance evaluations and reviews.

 

  Achieved all labor efficiency and material usage goals.

  Gained rapid promotion to manage teams as Group Leader.

 

Education & Professional Development

 

Emporia State University

 

Bachelor of Science in Business Administration

 

Six Sigma Green Belt

Situational Leadership Training

Fundamentals of Lyophilization

 

Member, Parenteral Drug Association (PDA)

 

Excellent Professional References Provided Upon Request

 

Yyyyyy x. yyyyyy

2424 NW Majestic Ridge Drive Bend, OR 97703 (xxx-xxx-xxxx abc@xyz.com

 

 

 

Date

 

Hiring Agent Name

Company Name

Address

City/State/Zip Code

 

Dear__________________:

 

I am exploring a new career opportunity within a challenging [ Insert Job Title ] role, and I believe that I can make a positive contribution to your bottom-line performance.

 

To acquaint you with my background, I can offer proven experience in Pharmaceutical Manufacturing, Production Center Management, Team Building / Training, Strategic Analysis / Planning, Quality Control / Assurance, and Facility Audits. I am also highly skilled in Continuous Process Improvements, Multi-Process Optimization, GMP, Lean / Six Sigma Methodologies, Corrective Actions, and Regulatory Compliance, among other areas.

 

Currently, as the Director of Commercial Manufacturing for Bend Research, I expertly lead all manufacturing initiatives for state-of-the-art production, including directing efforts for approved products to be manufactured on schedule and within quality and cost objectives. Within this role, I seamlessly liaise among Quality Control, Product Development, Engineering, and Finance teams to create and grow commercial manufacturing processes, and establish metrics to promote results-driven decision-making.

 

A sampling of my achievements include:

 

  Increasing production output by 125% within a one-year period.

  Successfully increasing production standards to exceed manufacturing goals.

  Interfacing with QA teams to re-establish EU certification for GMP manufacturing in one year.

 

To complement this experience, please note that I earned a Bachelor of Science in Business Administration from Emporia State University. I hold a Six Sigma Green Belt and completed additional training in Situational Leadership and on the Fundamentals of Lyophilization.

 

[ Suggestion! Optional! Address Here Any Skills / Qualifications / Achievements Relevant to the Job Posting. REMOVE this before sending]. As this is just an example of my abilities, please refer to my enclosed resume for additional experience in manufacturing / production management, manufacturing analyst, and quality supervisor roles.

 

As a proven leader, you will find that I am positioned to deliver both immediate and long-term results with a continued commitment to exceeding your team s goals. I am eager to discuss how my qualifications uniquely match your current and future needs, and look forward to interviewing with you soon.

 

Sincerely,

 

 

 

Mark Caylor

 

 

 

 

Yyyyyy x. yyyyyy

2424 NW Majestic Ridge Drive Bend, OR 97703 (xxx-xxx-xxxx abc@xyz.com

 

 

 

 

 

 

 

Date

 

Hiring Agent Name

Company Name

Address

City/State/Zip Code

 

Dear__________________:

 

I would like to thank you for providing me with the opportunity to interview for the [ Insert Job Title ] position currently available within your company. Having gained a deeper insight into the job requirements, I am confident that you will find me to be an incredible asset toward achieving your goals.

 

As previously discussed, I am a cross-functional leader who offers proven experience in Pharmaceutical Manufacturing, Production Center Management, Team Building / Training, Strategic Analysis / Planning, Quality Control / Assurance, and Facility Audits, as well as talents in Continuous Process Improvements, Multi-Process Optimization, GMP, Lean / Six Sigma Methodologies, Corrective Actions, and Regulatory Compliance. Please recall that I earned a Bachelor of Science in Business Administration from Emporia State University. I hold a Six Sigma Green Belt and completed additional training in Situational Leadership and on the Fundamentals of Lyophilization.

 

Throughout my career, I have excelled in progressive manufacturing / production management, manufacturing analyst, and quality supervisor roles for high-profile Bend Research, Pacira Pharmaceuticals, Ben Venue Laboratories, and Boehringer Ingelheim, to name a few, where I successfully led high-volume, on-time, and under-budget pharmaceutical manufacturing and production processes while mentoring and managing top-performing teams, driving continuous improvement and Lean manufacturing initiatives, and collaborating with the FDA and third-party customers during facility-wide audits to exceed compliance and organizational expectations to continually deliver world-class products and services. [ Suggestion! Address Here Any Relevant Skills / Qualifications / Achievements Discussed During Your Interview ] For the sum of these reasons, I am confident that I can attain success in a rewarding [ Insert Job Title ] role within your company.

 

I look forward to hearing a positive response from you, and thank you again for the personal interview.

 

Sincerely,

 

 

 

Mark Caylor

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