David Otte
Dracut,MA
Summary
Experienced Quality Control Analyst with demonstrated track record of improving products and procedures by leveraging hands-on inspections, testing methods and data analysis. Disciplined professional with systematic approach to problem solving and troubleshooting. Applies excellent attention to detail and critical reasoning to successfully conduct experiments.
Overview
42
42
years of professional experience
1
1
Certification
Work History
Senior QC Analyst II
REPLIGEN CORPORATION
02.2021 - 06.2024
- Responsibilities are like Senior QC Analyst I, with continued education and experience with SDS-PAGE and IEF electrophoresis to enhance analytical and bioprocessing skills
- Assisted in start-up of Protein A, CH1 Ligand, and assisted in development of all analytical test methods for fermentation to achieve IgG concentration, as well as purification methods for QC release testing
- Appointed as lead for CH1 Accelerated and Real Time Stability Studies
- I was also responsible for the Charles River NGL-Impact CH1 Endosafe Method Transfer to QC Repligen, which demonstrated the ability of the Nexgen-MCS Systems at QC Repligen to quantitate endotoxin level in NGL-Impact CH1
- Executed all testing and drafted report to summarize and support all results per parameters of protocol
- Appointed QC representative to EHS Committee Membership Charter, and completed EHS Risk Management for QC Heat Mapping with Priority Tasks Risks
- These projects demonstrate abilities as a self-starter, personal contributor to QC Team and EHS Safety Committee, and leadership qualities to take on and successfully complete assigned tasks to assist colleagues.
- Edited, proofed, and critiqued internal documents to improve clarity.
- Participated in departmental meetings to establish short- and long-term strategy.
- Monitored KPIs to proactively address bottlenecks and quality issues.
Senior QC Analyst I
REPLIGEN CORPORATION
11.2017 - 02.2021
- Working knowledge of all applicable regulations and requirements, as pertinent to Repligen Corporation.
- Subject matter expert (SME) in several areas of responsibility, e.g., analytical chemistry and microbiology analysis
- Sought by peers and subordinates for technical, product process, and systems knowledge
- Use professional concepts to develop more efficient processes.
- Demonstrated leadership abilities by effectively leading Quality Team to meet and exceed customer requirements, for release of finished product to satisfy all shipping timelines
- Lead by example. Respected by colleagues and maintain high degree of commitment towards excellence.
- This is achieved by setting high and motivating standards for myself, peers, and subordinates
- Proficient in oral and written communication skills and demonstrate good presentation skills
- Maintain open line and proficient communication with manger, peers, and subordinates.
- Provide training and mentoring to new colleagues, peers, and subordinates, and maintain ability to lead in team environment by delegating responsibilities to team when required
- Continue to evaluate Personal Growth and Development Objectives annually
- Continue with self-development by attending courses e.g., Agilent Infinity I and II Series Troubleshooting and Maintenance and Fred Pryor - Transitioning to Supervisor.
Q.C. Chemistry Analyst II
ANIKA THERAPEUTICS, INC.
10.2012 - 11.2017
- Responsibilities were same as Analyst I, with addition of analytical assays such as GC, Karl Fischer, FT-IR, and USP/EP raw materials testing under cGMP guidelines when required
- Required to use mechanical instruments e.g., digital micrometer and thickness gauge to perform dimensional analysis of bio-material textiles.
Q.C. Chemistry Analyst I
ANIKA THERAPEUTICS, INC.
06.2011 - 10.2012
- Perform various analytical assays such as HPLC, UV/Vis, TOC, and wet chemistry analyses for in-process and finished formulations, stability, engineering, and R&D samples under cGMP guidelines.
Q.C. Chemistry Specialist II
FORMATECH, INC.
05.2001 - 05.2011
- Performed analyses of raw materials, in-process, release, and stability samples by HPLC, UV spectroscopy, TOC, osmolality, specific gravity, viscosity, pH, conductivity, lyophilized and liquid appearance.
- Collaborated with cross-functional teams to optimize chemical processes and reduce production costs.
Chemical Hygiene Officer
FORMATECH, INC.
06.2005 - 05.2011
- Implemented EHS programs and policies, e.g., New Employee Safety Orientation, Emergency Response, and Hot Work
- Revised and improved Chemical Hygiene, HAZCOM, and Exposure Control Plans, and was lead for all safety training, e.g., annual refresher task specific training
- Performed industrial hygiene and ergonomic evaluations, job risk assessments, submitted required reports, maintained regulatory documentation, audited site operations for compliance and implementation of EHS best practices.
- Conducted thorough investigations into complex cases, leading to successful resolution of numerous high-profile incidents.
Cell Culture Associate
UNYSIN TECHNOLOGIES
10.2000 - 05.2001
- Performed cell culture operations via hollow-fiber bioreactors in production of master/working cell banks for various pharmaceutical companies
- Write investigation reports of microbial contaminations, process deviations, revising procedures, production batch records, and training new team members
- Supported and assisted other departments with Q.A., Q.C., and regulatory issues.
- Aided in implementation of employee-training program to adhere to CGMP standards.
Senior Q.C. Technician
PFIZER (Formerly: Wyeth Ayerst at Genetics Institute)
08.1997 - 09.2000
- Performed in-process testing such as kinetic-chromogenic LAL, gel clot LAL, bioburden, mycoplasma, conductivity, and biological indicator spore strip testing
- Performed rapid microbial identification with VITEK, all in support of clinical manufacturing.
- Maintained safe work environment by adhering to established safety protocols, reporting potential hazards, and participating in safety trainings.
Process Technician
PFIZER (Formerly Genetics Institute)
08.1996 - 08.1997
- Worked in clinical manufacturing of rFIX and IL-11 and was involved with final FDA inspections of both products
- Worked in commercial manufacturing of rhAHF
- Performed thawing and transferring of mammalian cells using aseptic technique, determined viability and density of cells, maintained spinner flasks, and prepared samples for final product testing and purification.
Electronic Troubleshooter / Q.A. Team Leader
RAYTHEON COMPANY (MSD)
04.1982 - 06.1996
- Evaluated and troubleshot guidance systems of various surface-to-air missiles.
- Member of Raytheon Team Quality, and QA Team Leader from Sep 1994 through June 1996
- Conducted meetings with team members and performed various department audits, in pursuit of producing quality products through continuous process improvement
- This work was all in pursuit of producing quality products through continuous process improvement
- Responsible for presenting team’s accomplishments at semi-annual meeting with plant manager and his staff.
- In 1995 our team earned award as “Most Improved Test Team” with quality improvement of 53.33%.
Education
Certificate - Biotechnology Science
MIDDLESEX COMMUNITY COLLEGE
Lowell, MA12.1996
Certificate - Environmental, Health, And Safety
Columbia Southern University
Orange Beach, AL12.2005
Associate of Science - Electronics Technology
FITCHBURG STATE COLLEGE
Raytheon In-House Education01.1991
Skills
- Compliance with Quality Management Systems, eg, ISO-9001 and 13485, GMP 21CFR-Part 11, 210, 211, 600, and 820 Also experienced with ICH Q7A, USP, EP, and EU Annex 1
- Canae One, SAP, EDMS, Velocity EHS, LIMS, and Master Control experience
- Analysis experience with HPLC, GC, UV-Vis, KF, FTIR, Viscosity, SDS-PAGE, IEF, pH, conductivity, endotoxin, and bioburden determination
- Delegate laboratory responsibilities
- 6S Lean Laboratory methodology
- Write and review Standard Operating Procedures (SOP), Test Methods (TM), Batch Records, and Validation Documentations
- Document and execute quality systems including generation of Certificate of Analysis (CoA) Deviations, Out-of-Specifications (OOS), Quality Investigations, Root Cause Analysis (RCA), Corrective Action / Preventative Action (CAPA), Non-Conforming Material Reports (NCMR), Change Controls
- Personal training and team development
- Internal / External Compliance Auditing
Certification
- Agilent Infinity I and II Series Troubleshooting and Maintenance
- Transitioning to Supervisor
- Developing Emotional Intelligence
- Critical Process Cleaning and Cleaning Validation
- Principle Operation and Viscosity Measurement
- OSHA (30 hour), EPA (RCRA), DOT
- CPR with AED / First Aid
Timeline
Senior QC Analyst II
REPLIGEN CORPORATION
02.2021 - 06.2024
Senior QC Analyst I
REPLIGEN CORPORATION
11.2017 - 02.2021
Q.C. Chemistry Analyst II
ANIKA THERAPEUTICS, INC.
10.2012 - 11.2017
Q.C. Chemistry Analyst I
ANIKA THERAPEUTICS, INC.
06.2011 - 10.2012
Chemical Hygiene Officer
FORMATECH, INC.
06.2005 - 05.2011
Q.C. Chemistry Specialist II
FORMATECH, INC.
05.2001 - 05.2011
Cell Culture Associate
UNYSIN TECHNOLOGIES
10.2000 - 05.2001
Senior Q.C. Technician
PFIZER (Formerly: Wyeth Ayerst at Genetics Institute)
08.1997 - 09.2000
Process Technician
PFIZER (Formerly Genetics Institute)
08.1996 - 08.1997
Electronic Troubleshooter / Q.A. Team Leader
RAYTHEON COMPANY (MSD)
04.1982 - 06.1996
Certificate - Biotechnology Science
MIDDLESEX COMMUNITY COLLEGE
Certificate - Environmental, Health, And Safety
Columbia Southern University
Associate of Science - Electronics Technology
FITCHBURG STATE COLLEGE
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