Drug Product Cover Letter

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

Previously, I was responsible for eU regulatory strategic input, liaise with EMA as primary regulatory contact and with other EU NCA, ensure EU labeling (Annexes and associated documents) remains in compliance with CCDS and EU/ICH regulations, be responsible for and contribute to ensuring creation, critical review, finalization of EU specific regulatory documents i.e.

Please consider my qualifications and experience:

• Develop/optimize/characterize processes for the manufacturing of sterile products
• Previous experience writing technical documentation (SOP’s, preventative actions, deviations, reports) preferred
• Strong listening and interpretive skills to successfully translate events into clearly written documents
• Detail oriented with very strong English writing skills
• Scientific experience in GMP regulated industry
• Working knowledge of analytical methodologies and analytical instruments qualification programs
• Knowledge in mechanics of materials, glass forensic and polymers forensics
• Fluent communications skills in English and Spanish

Please consider me for the drug product opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for r&D engineering support for Quality and compliance activities including correcting quality problems in released product, compliance with new regulations and standards, and remediation of quality findings.

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:

• Effective verbal communication, presentation, and technical writing skills
• Experience across various solid oral dosage conventional and enabling manufacturing technologies
• Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals
• Experience with broad CMC issues encountered in drug development, thorough understanding of applicable regulations, and experience with authoring relevant sections of regulatory filings (INDs/NDAs)
• Working knowledge of cross-functional drug development processes, FDA/ICH/EMA guidelines and cGMPs
• Knowledge of cGMP, contracts, supply agreements, and quality systems as it relates to Contract Manufacturing Organizations
• Full understanding of complex technical issues in drug product manufacturing and packaging
• Hands on experience with commercial drug product fill / finish manufacturing

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

In my previous role, I was responsible for guidance on emerging regulations or changes in standards and regulations and oversee product safety training requirements.

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:

• CDMO and/or knowledge of pharmaceutical development preferred
• Broad understanding of brand and product management principles
• PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline with excellent theoretical and scientific knowledge
• Excellent scientific project management and leadership skills
• Has experienced in working with contract manufacturing and contract research organizations
• Has deep technical understanding of all aspects pertaining formulation and drug product development of liquid and lyophilized biological products, including experience with multiple primary packaging configurations and combination products
• Proficient in Excel, PowerPoint, Word, in addition to experience working within shared work environments (ie SharePoint, Box, eRoom)
• Exhibits confidence and has strong interpersonal, written and oral communication skills for providing team updates

Please consider me for the drug product opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for subject matter expertise and guidance interpreting global regulations, guidelines, and define internal requirements to ensure compliance.

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

• Gains understanding from provided instructions and works towards goals with minimal supervision
• Experience working within GMP/Quality systems
• Shows flexibility and willingness to collaborate in the face of challenges and adversarial situations
• Associate Specialist
• Senior Specialist
• Technical experience with Aseptic Filling and Packaging operations and maintenance
• Technical experience with Autoclave operations and maintenance
• Experience in process and/or machine validation

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

Previously, I was responsible for expert quality guidance for internal and exter-nal parties related to GMP quality standards, relevant quality guidelines, regulations and requirements for manufacturing and testing, including expectations for CGT Product in both early and late clinical phase, in preparation for commercialization.

Please consider my qualifications and experience:

• Hands on experience with commercial drug product global packaging requirements
• Experience in leading CMO relationships
• Bachelor of Science in Marketing, Business Administration or related field
• Broad Operations background in Pharmaceutical Industry with experience in Drug Product Development, specifically sound knowledge in drug product process development, scale-up and production
• Strong team-player with strategic mindset and fluent English and German skills in writing and speaking
• Senior sales leadership acumen in the CMO, API , CRO or pharmaceutical/biotech partner sector
• BS in Engineering or appropriate scientific or business acumen
• Knowledge and experience of biopharmaceutical formulation and process process development of liquid is preferred