Medical Device Tech Transfer

SALMA SIRAJ

Cell #: 408-***-****

Email: *******@*****.***

OBJECTIVE:

To obtain senior level technical management position in chemistry or biochemistry in pharmaceutical, medical device or biotechnology company that develops innovative products.

HIGHLIGHTED ACCOMPLISHMENTS:

Lead analytical team to oversee the schedule. Review and approve goals and development plan for direct reports. Conduct performance review and calibration for compensation.

Over see Contract lab and CDMO on process, tech transfer, and troubleshooting.

Successfully led drug products testing for various product lines from early feasibility stage (Pre IND) through phase III (NDA) in a cGMP environment. Experienced in the different phases of method requirements with emphasis in phase II and phase III stages through commercialization.

Successfully lead the analytical method development and validation and method transfer activities of API, early phase and late phase analytical test attributes, including impurity, assay, content uniformity, assay, and dissolution methods.

Established environmental monitoring, shelf life, and stability program for Rodan and Fields, Tate and Lyle ingredient platform, baby meals and drink platform at Nestle and sunscreen and skin care products at Neutrogena and various pharmaceutical products at Alza JNJ.

EXPERIENCE:

Rodan and Fields, Research, Innovation and Quality

Sr. Manager R&D and Quality (Aug 2017 to Cont.)

Lead the quality team to develop and validate analytical methods for new formulation and to support in-house informal stability program. Over see daily activities, documentations, instrument calibration, and AOP. Work closely with Regulatory and clinical to ensure the quality and compliance process.

Oversee, Contract labs, CMO/CDMO for tech transfer, compliance, process, and troubleshooting.

Establish internal analytical lab and set up the informal stability program in-house to support R&D and new product development. Hire and train lab staff, evaluate and implement new laboratory technologies for efficiency and cost saving.

Manage formal stability program to support product shelf life, expiration, storage, and transit program.

Select contract labs for formal stability program and product release, qualify them for compliance and GMP per FDA and Health Canada requirement.

Conduct external GMP audit at contract lab, supplier, and contract manufacture in compliance with FDA, Health Canada, and ISO.

Manage, review, and approve analytical method development, validation/ verification, and transfer for new and existing test method to support North America and global market.

Review and approve stability protocols, evaluate, track and trend data. Write final stability reports.

Lead all OOS/ OOT, deviation, and investigation internal and external to close in timely manner. Track and trend OOS, write SOPs, justification, deviations, change control and other GMP documents to support products manufacturing system.

Manage commercial product releases for global market to ensure quality and compliance. Review investigations, deviation, and CAPA.

SME for analytical guidance and product shelf life for product development, regulatory, QA, and legal.

Write justification, CMC, annual product review, and other scientific document to support QA and QC initiatives.

Hire and train Quality staff. Over see their goals and objective to ensure employee growth.

Tate and Lyle Research, ICD (Innovation and Consumer Development)

Principal Scientist (Sep. 2016 – Aug 2017)

Sr. Research Scientist Analytical/ group Lead (July 2011 – Sep. 2016)

Direct supervision for associate scientists and group lead for separation lab.

Lead stability / shelf-life study program and oversee stability design and execution, LIMS stability module and train NPD and application staff to execute the shelf life studies under regulatory environment for new and existing products. Led all OOS and investigation.

Review protocol and provide technical feedback based on ICH and internal guideline to support filling and nutritional claim.

Analyze and track data for scoping studies, DOE, shelf life and stability studies and provide technical input to the team of internal and outside customers, regulatory and nutritional group.

Review and approve investigation and deviation and provide technical input and training to the staff.

Troubleshoot degradation products and other unknown by LCMS and ICMS.

Safety mentor for the analytical staff and provide technical presentations for annual OSHA training for NPD staff.

Participate in IP and patent activities and write supporting documents.

Develop and validate analytical methods for new ingredients including natural products for the use of zero calories/ reduce sugar application (novel oligosaccharides, glycosides, functional/ rare sugars, other carbohydrate, texturant, and fiber) using HPLC/ UPLC, ELSD/CAD, IC, GC, GPC, and LCMS.

Collaboration work with Agilent to evaluate remote UPLC plan to support plant trials at various location nationwide as part of innovation, time, and cost saving initiatives. Successfully implement remote UPLC set up to support plant trials for high throughput.

Nestle, Product Technology Center

Sr. Scientist Analytical (Oct 2009 – July 2011)

Providing technical consultation, guidance, and support for development of infant meals and drinks platform.

Developing and validating test methods for infant meals and drinks using GC, HPLC, and IC technologies.

Leading the stability and shelf life monitoring program for baby meals and drink and introduce the concept of accelerated shelf life model.

Review and approve the stability protocol for stability studies to support shelf life. Tracking and trending the stability studies, OOS, and investigations.

Johnson & Johnson Neutrogena

Senior Scientist, Analytical Development (Dec. 2007- 2009)

Providing technical consultation, guidance, and support for development of cosmetics, cosmetic devices, and OTC drug products.

Developing and validating test methods for raw materials, bulks, and finished products and modifying test methods to improve efficiency, robustness, compliance, and costs.

Coordinating and conducting method transfers to external and internal testing labs / manufacturing sites.

Review and approved the stability protocol for stability studies to support shelf life. Tracking and trending the stability studies, calculating expiration dating, and writing stability reports for product release.

Implement the OOS/Deviation tracking system at Neutrogena analytical R&D. Responsible for maintaining and tracking the system for the analytical R&D. Review the final report, summarize, and write the quarterly reports for OOS/ Deviation track and trend analysis.

Implementation of new chromatographic system to analytical, working in the team to support the new system requirement, validation, and implementation of Empower to all the J&J consumer sites. Perform administration activities for Empower at Neutrogena analytical site.

Johnson & Johnson West Coast Chem Pharm – ALZA Corporation

2007 - 2007 Sr. Associate Scientist

2006 - 2007 Associate Scientist

2004 - 2006 Analytical Chemist III

2001 - 2004 Analytical Chemist II

Successfully leading the analytical method development and validation activities of early phase and late phase analytical test attribute, including impurity, assay, content uniformity, drug release and dissolution methods.

Design and perform design of experiment (DOEs) for method robustness and analyze data using statistical tools like Minitab and JMP.

Design and perform compatibility and forced degradation studies for excipients and finished products for stability studies.

Perform impurity assay, release rate, content uniformity, stability, and API testing to support OROS formulations and lot clearances.

Perform stability studies for intermediate and finished products under cGMP guidelines.

Involve with Drug enforcement agency (DEA), analytical Project Lead (APL), Quality Assurance (QA), internal projects.

Maintain and troubleshoot chromatographic equipment with metrology and hardware validation group.

Participate in process improvement activities like enterprise team, scientific leadership group, compliance issues and other general training issues.

Review analytical data packages and reports.

Conduct all the investigation work to support for clinical/ commercial work.

Johnson & Johnson Life Scan

Quality Assurance Analyst (Apr 2001-Jul 2001)

Research Chemist (May 1999-Apr 2000)

Generate stability protocol, monitor stability chamber and pulled samples for testing to support the shelf life and stability studies.

Participate in method development, validation, and clinical studies.

SKILLS:

Quantitative and qualitative analysis techniques (LCMS, LCMSD, HPLC, IC, FT-IR, UV-Vis, NIR, LC-MS, CE, GPC, ICP, and GC).

Chromatographic data acquisition systems such as TotalChrom, ChemStation/ open lab, Chromeleon, Empower, Mass Hunter, and Mass Lynx.

Statistical programs such as Stat Ease, JMP, Statistica, Mini Tab, Nova Manage

Proficient in cGMP, FDA Guidance documents, ICH Guidelines and ISO, CAPA, OOS, Deviation.

QMS software, SAP, Veeva,

Computer savvy in Word, Excel and PowerPoint, LIMS, ELN

AFFILIATIONS:

Society of Cosmetic Chemistry, AAPC, AOAC, ACS, American Society for Quality, IFT, PCPC

EDUCATION:

Master of Science, Biochemistry - Dec 1994

University of Karachi

Analytical Chemistry Courses (1996 – 2001)

San Jose State University, San Jose, CA

Bachelor of Science (BS Honor) - May 1993

University of Karachi

REFERENCES:

Available upon request.

Contact this candidate