Drug Substance Cover Letter

I submit this application to express my sincere interest in the drug substance position.

In my previous role, I was responsible for technical support of cGMP manufacturing at CMOs including authoring of technology transfer documents, supporting change controls, closing manufacturing investigations, and helping validation actives.

Please consider my experience and qualifications for this position:

• Strong problem-solving skills Experience leading and managing groups of at least 15 PhD/MS/BS scientists, engineers, and cross-functional project teams
• Familiar with Microsoft Office applications is strongly preferred
• Requires strong understanding of technology transfer, process fit analysis, scale-up/down, and process validation
• Extensive experience in managing contract manufacturing companies
• Strong project leadership and resource management skills along with good verbal and communication skills
• Drive towards timely decision making and escalate issues appropriately
• Proven track record in developing and scaling-up innovative, safe, and effective processes for the manufacture of chemical intermediates and drug substances
• MSc or PhD desirable

In response to your job posting for drug substance, I am including this letter and my resume for your review.

In my previous role, I was responsible for on-the-floor technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation.

Please consider my experience and qualifications for this position:

• Work closely with supply chain and finance to develop a robust drug inventory control based on the rate of drug utilization and forecast model
• Manage the manufacturing activities at contract organizations worldwide
• Trend process performance by establishing relevant metrics
• Identify and implement opportunities to improve process performance
• Support regulatory submissions by writing and reviewing drug substance related sections
• Management of clinical trial material supply for late phase development
• Execution of GMP intermediates and drug substance commercial process validation and preparation for manufacturing site with pre-approval inspection
• Working knowledge of relevant ICH guidelines

I am excited to be applying for the position of drug substance. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for review, approval and tracking of cGMP processes, procedures, assays, documents and records, including Nonconformances, CAPAs, and validations.

My experience is an excellent fit for the list of requirements in this job:

• Comprehensive know how in pharmaceutical (chemical) technology
• Strong foundation in biochemical engineering or related discipline
• Able to demonstrate sound clinical decision making under pressure
• Able to recognize own boundaries of practice
• Hands-on cell clone isolation and single cell cloning
• BSc in virology, molecular biology, cell biology or other vaccinology related discipline
• Basic experience with common bio analytical assay execution (ELISA, SDS-PAGE, Western blot, PCR assays)—analytics side
• MSc in virology, molecular biology, cell biology or other vaccinology related discipline

I am excited to be applying for the position of drug substance. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for scientific expert leadership to an Upstream, Downstream or Analytical team (scientists and associates) in the development of processes in support of phase I-III clinical supply through to commercial supply.

Please consider my experience and qualifications for this position:

• Experience with statistical data analysis such as linear models, multivariate analysis, and stochastic models
• Experience with Agile/Iterative Software Development Lifecycle (SDLC)
• Education discipline/background in Electrical Engineering
• Demonstrated record of implementing creative, efficient, and effective solutions to overcome project obstacles, integrating efforts with specialists from other functional disciplines
• Related experience should be in GMP-regulated industries in Quality Control
• Background in lean manufacturing methodologies and operational excellence
• Represent Technical Operations on program teams
• Work closely with cross-functional teams and external partners to prepare CMC strategies and develop drug substance process validation and commercial production plans

I submit this application to express my sincere interest in the drug substance position.

In the previous role, I was responsible for quality oversight of cGMP external drug substance manufacturing operations.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Strong writing/communication skills and experience with change control
• Experience with Process Control System (PCS) and Manufacturing Execution System (MES) specification, implementation and use
• Scale-up of cell culture and downstream processes for viral based products to pilot-scale and tech transfer of the process to GMP manufacturing facility is preferred
• Thorough understanding of bio-process development, Quality by Design, PAT, Method Qualification and Assay (performance) characterization
• Direct and proven CMO and Manufacturing Operations experience, including tech transfer, validation and commercial scale production of small molecule Drug Substances
• Demonstrated success in project planning, resource management, and collaboration with Development, Quality and development CMC
• Knowledge of how to negotiate and manage contracts, and establish and control budgets
• Strong knowledge of biotech/pharma small molecule manufacturing operations, and product and process development