Rohan Narayanan Email & Phone Number

Los Angeles, CA, US

Baar, CH

• Lead quality personnel in charge of releasing finished product
• Lead quality representative liaising with other departments and clients to resolve quality issues in order to release product
• Final QA approver of finished product certificates of analysis, executed batch production records, deviations, CAPAs, OOS, investigations, and process change controls
• Lead quality personnel in charge of releasing new equipment and approving associated validation and qualification documents.
• Key contributor in client and FDA audits

Baar, CH

• Reviews executed batch records and collaborates with production personnel to ensure good documentation practices are being employed
• Reviews QC analytical release data and generates certificates of analysis
• Initiates and reviews engineering change requests and provide quality support for any relevant engineering activities
• Reviews deviations and CAPAs prior to review by the final QA approver
• Releases raw materials for use in production

Baar, CH

• Reviews executed batch production records
• Generates shipping labels for finished product
• Reviews calibration and preventative maintenance reports
• Initiates and processes engineering change requests
• Supports issuance of batch production records

Santa Monica, California, US

Reviews manufacturing production records for good documentation practices and compliance with standard operating procedures.ISO-7 and ISO-8 gown qualified.Assists with inventory management of QA batch record roomPerforms final review of aseptic operator qualification recordsReviews IL-2 and media manufacturing records prior to release for production use.

Foster City, CA, US

• Assisting with various ongoing projects within the department.
• Primary project entails performing data analytics to improve a specific process in AmBisome intermediate manufacturing
• Developing and revising SOPS for document and sample control within Technical Services

Azusa, CA, US

• Undergoing a multidisciplinary program to learn about the various aspects of the biotechnology and pharmaceutical industry and to propel myself into a management position within the industry as well.
• Courses include biopharmaceutics, bioinformatics, regulatory affairs, advanced statistics and probability, project management, etc.

Sant Cugat Del Vallès, Barcelona, ES

• Tasked with different projects that involve quality assurance and regulatory compliance knowledge
• Analyzed upcoming EU annex 1 GMP regulations and comparing them with current company practices in order to determine if the company is in compliance with these future regulations
• Assisted with a CBE-30 submission to the FDA following the installation of a new freeze dryer. Tasked with drafting the submission as well as reviewing validation and qualification protocols that will be included in.
• Analyzed excipient supplier audits and verifying that suppliers are in accordance with company GMPs.
• Periodically reviewed validation and qualification protocols before they are approved for implementation

Los Angeles, CA, US

• Promoted early from student internship program due to consistently exceeding expectations and showing initiative in becoming involved in multiple projects.
• Assisted post-docs with ongoing projects that led to co-authorship in five publications.
• Assisted with lab equipment maintenance and helped manage inventory.
• Trained international interns in good lab practices and techniques. Managed their PI-assigned projects by mapping out their experiment schedule and supervising them on a day-to-day basis. Under my supervision, three.

Los Angeles, CA, US

• Acquired and mastered molecular biology lab techniques essential for future projects.
• Successfully completed my first independent project that provided valuable experimental data that led to future projects.
• Expanded knowledge of pulmonary diseases through attending various seminars held by experts in the field.

• Improved patient flow in the emergency room by completing electronic medical charts while collaborating closely with ER physicians.
• Gained expertise with electronic medical charting programs, ie Cerner Millennium.

Master Of Science - Ms, Biotechnology

Bachelor Of Science (B.S.), Neuroscience

High School Diploma