Development Chemst / Lab Supervisor

RESUME

The vast majority of my working life has been with Warner Chilcott (formerly Galen Ltd.). Warner Chilcott is a leading specialty pharmaceutical company focused on the women’s healthcare and dermatology segments of the U.S. market. They have a manufacturing base in Fajardo (Puerto Rico), manufacturing and formulation/development facilities in Larne (Northern Ireland) and a corporate office in New Jersey (U.S.). Current U.S. market products which i personally worked on to varying degrees include: Estrostep, Loestrin 24, Femring, Femhrt, Estrace Cream and Tablets, Femtrace, Femcon, Sarafem and Doryx.

EMPLOYMENT SUMMARY

Warner Chilcott UK 2008 - 2009 Development Chemist / Lab Supervisor

£ 36,500 PA +bonus

Key Duties/Responsibilities:

Laboratory Management and Planning; Held Responsibility for Overall Laboratory Status, with respect to Staff (approximately 30 lab staff), Equipment and Materials, ensuring Qualification, Calibration and Training was in Compliance to GMP and Quality Standards.

Leading Trouble Shooting / Multiple Function Task Teams; Several Years of Successfully Leading Analytical Teams, either in Isolation or as a Limb of a Project Team, having to Co-ordinate and Communicate Effectively across Departments. Further, several years operating as part of and often Heading cross-functional multi disciplinary Project Teams to tight deadlines; Coordinating Method Development, Validations and Transfers.

Acted as a Trouble Shooter and Analytical / Technical Support for Laboratories in the U.S., while Building the Relationships between the Laboratories to Effect Improved Communication and thus Faster Response on Multi-Laboratory Project issues.

Preparing Documentation – SOPs, Reports, Site Guidelines, Stability/Development Protocols and Specifications.

Identification of new Technologies, Subsequent Budgeting, Equipment Purchase, Qualification and Training.

Lead innovation at Warner Chilcott, heading up the New Chemical Entity projects. Operating with new materials and technologies, while forging a new path for the Company and creating valuable relationships with Chemical synthesis and Clinical teams across multiple countries.

New Product Development, following on into Pre-Clinical and Clinical Trials, Internal and External auditing of Procedures, Systems and Sites with respect to ensuring Quality and identifying opportunities to Improve Operational Efficiency.

Lead Audit/Review Teams through Complete Project Reviews in preparation for FDA Submissions and Audits. Also internal audits in preparation for MHRA or FDA audits.

Drove Continuous Improvement schemes and Internal Cultural changes to Increase Team and Personal Skills/Performance; Personally Lead Departmental Training sessions, 360 degree Feedback and Mentoring Programs.

McNiece Enterprises LLC 2007 - 2008 Owner / Manager

Approx. $6,000 net per month

Key Duties/Responsibilities:

Advertising and Marketing of Services, Negotiating with Clients, Ensuring Customer Satisfaction and Dealing with Complaints Sourcing and Dealing with Sub-Contractors.

Hiring and Managing Two Independent Teams of Employees, Planning Daily/Weekly Schedules, Supervising and Inspecting Work and Equipment.

Financial Management of Business, Budgeting for Resources, Producing Detailed Contracts and Quotes for Clients, Billing of Clients.

Warner Chilcott UK 2005 - 2007 Development Chemist / Lab Supervisor

£ 29,500 to £ 33,500 PA +bonus

Key Duties/Responsibilities:

As detailed under most recent position.

Warner Chilcott UK 2002 - 2005 Senior Analyst

£ 19,500 to £ 26,500 PA

Key Duties/Responsibilities:

Supervising Multiple small (4 to 8 individuals) Groups working on Specific Projects, Leading Analytical Projects including New Product Development.

Equipment Qualification with Risk Assessment of Operations and Procedures, Maintenance and Repair of Equipment.

Method Development, Validations and Transfers.

Training Staff, Environmental Monitoring, Microbial Analysis.

Producing Documentation, e.g. Stability Protocols, Operating Procedures, Specifications and Study Reports.

Quality Control / Reviewing Data and Documentation.

Galen Ltd./Warner Chilcott UK 1998 - 2002 Laboratory Analyst

£ 12,500 to £ 18,500 PA

Key Duties/Responsibilities:

In-Process and Quality Control Testing, Assisting Formulation on Product Development Studies, Assisting Manufacturing on New Product Trials.

Environmental Monitoring, Microbial Analysis and Waste Management.

Purchasing Laboratory Consumables and Specialty Chemicals.

Training Staff, Environmental Monitoring, Microbial Analysis.

Stability Room Management, Equipment Calibration and Maintenance / Repairs.

Galen Ltd. 1998 – 1998 Laboratory Technician

£ 10,500 PA

Key Duties/Responsibilities:

Raw Material and In-Process Testing, Assisting Manufacturing on New Product Trials.

Environmental Monitoring, Microbial Analysis and Waste Management.

Stability Room Management, Equipment Calibration and Maintenance / Repairs.

Randox Laboratories 1995 - 1996 Laboratory Technician

£ 9,500 PA

Key Duties/Responsibilities:

Raw Material and In-Process Testing, Assisting Manufacturing and Packaging Departments.

Environmental Monitoring, Microbial Analysis and Waste Management.

Enzyme Extraction and Purification.

PERSONAL PROFILE

After graduating from the University of Ulster I found my way into Galen Ltd. (now know as Warner Chilcott) as an entry level Laboratory Technician. Demonstrating my desire to succeed and my adaptability I progressed at a measured pace within the company. As the company changed and diversified, so did I, working within the fields of Manufacturing, Formulation Development, Quality Assurance and Pre-Clinical Studies along the way. With over 10 years of experience gathered from the lowest to the highest positions in a constantly evolving Pharmaceutical environment, I feel I can offer a blend of enthusiasm, leadership (formal and in-formal), innovative thinking and technical knowledge that is certainly above the norm. Towards the end of my time at Warner Chilcott, I also lead an intensive cultural change and continuous improvement scheme for the entire laboratory, introducing many new (to the lab) concepts such as 360 feedback and championing the growth and productive use of teamwork. With such an encompassing history at Warner Chilcott; I have also had the opportunity to work with many drug delivery systems also, including topical gels, tablets, chewable tablets, capsules, suspensions, intra-vaginal rings, transdermal patches, sub-lingual strips and creams. I have personally been involved with projects from conception, through development, regulatory submissions, product launches and eventually as multi million dollar products in the US market place. Highlighting my performance and abilities during my period at Warner Chilcott is the fact we never received any negative feedback (no 483s issued) from the FDA over the two major audits in which I was heavily involved.

A few years back, I took my leave of the Pharmaceutical field to run my own landscaping business, based in the Orlando area. With no prior experience, I feel my ability to absorb new things was proven as within months I was advising clients as to what shrubs to plant for their situation. Family matters called a halt to my time in the US and I returned to my old position again, but I soon realized that I still had the desire for a change; a fresh challenge to strengthen and develop new limbs of my skill base.

EDUCATION

University of Ulster

1993 – 1997

Jordanstown Campus, Shore Road, Newtownabbey, Co. Antrim, BT37 0QB

2:1 Honors B.Sc. Applied Biochemical Sciences

PERSONAL INFORMATION

Full Name: Richard McNiece

Current Address: 56 Parkgate road, Connor, Co. Antrim, BT42 3PF

Marital Status: Married

Date of Birth: 04/03/1976

Drivers License: Full, clean license

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

Telephone: 075**-******

REFERENCES

Robert J. Kessler, Ph.D.

Senior Manager Pharmaceutical Development

Warner Chilcott LLC, Enterprise Drive, Rockaway, NJ 07866

********@****.***

Margaret Fullerton

Senior Analytical Team Leader

Warner Chilcott UK, Old Belfast Road, Millbrook, Larne, N. Ireland. BT40 2SH

********.*********@****.**.**

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