100 million Plant expansion, Experience required of similar size.  

Product Transfer Experience.  

Superior pharma knowledge in QA, Mfg, Start-ups, etc. 

Current project management skills with Microsoft project and an ability to manage high level presentations to management.

Bi-lingual in Mandarin and English; Required. 

A preference and willing to locate in Taiwan for the next two years. After two years and completing this project the person can either remain at a Senior level in Taiwan or return to the US  in a Senior Vice President position. 

Compensation will be commensurate.

California

Salary Commensurate

Summary-The position insures the successful completion of various complex technical projects within supply chain operations through detailed coordination of internal and external resources. The incumbent ensures that all projects have timely reporting and visibility at the highest managerial levels. Determines the requirements for resources and makes recommendation to management. 

EDUCATION and/or EXPERIENCE 

Bachelor's degree, basic science or engineering preferred;  Pharmaceutical manufacturing or relevant industrial experience required and a minimum of ten years progressive management experience required, with a minimum of 5 years of direct experience in Project Management.   An MBA or other advanced degree is preferred.

California

Solid Dosage Experience required.

Base $85-90,000 

Work schedule, 3-12s, Days.

100,000+, 10% Bonus

Northwest - This is a Great company and a low cost of living area in the Pacific Northwest (40% lower than Los Angeles and 16% lower than Denver), relocation is required. 

The Manufacturing Manager has oversight responsibility for any of the manufacturing operations in either the SVP or Allergenics manufacturing departments.  The Primary responsibility of the Manufacturing Manager will be to manage the personnel and processes involved in the production of liquid parenterals in the SVP and/or Allergenics manufacturing operations.  Technical knowledge of aseptic processing, cGMP’s, FDA regulations, and organizational, and managerial, leadership skills will be used to effectively manage the department.

ESSENTIAL RESPONSIBILITIES

Manage all manufacturing activities occurring on all shifts.  This includes, but is not limited to the following areas:  Mycology, Raw Materials/Extractions, Supply Preparation, Sterile Filtration, Sterile Filling, Finishing, SVP production, SVP packaging, and all cleanroom sanitization activities.

Ensure a safe workplace and that all job activities are performed in a safe manner.

Administer disciplinary action, and provide coaching and counseling to improve the performance and morale of the Manufacturing department.

Maintain knowledge of state of the art parenteral manufacturing concepts, practices, and processes, including cGMP’s, and Aseptic Processing Guidelines.

Upper Midwest

$150-200,000 + Bonus

This position represents an opportunity to oversee all aspects of Quality Assurance for a rapidly-growing and extremely profitable bulk drug firm. Specific areas of responsibility include design and implementation of all quality systems, documentation, batch records, validation, product release, corrective/preventive actions (CAPA), FDA and other regulatory body escort/audits, oversee new employee training, etc. Specific knowledge of 21 CFR Parts 11, 210 and 211 are required along with a BS degree minimum in the life sciences - advanced degrees preferred, particularly Chemistry. We seek at least ten years of pharmaceutical industry QA leadership experience which may be in API's or finished dosage forms. The selected individual will have an opportunity to be a pro-active leader and make a significant impact on a company with a very bright future.

Key role in this quality organization charged with oversite of all validation activities for USP Clean Steam, Purified Water and WFI, Clean Compressed Gasses and Sterilization to include steam in place, autoclaves, terminal sterilization and parametric release, vaporized hydrogen peroxide, gamma, in-line sterile filtration and allied systems. Position will also be heavily involved in new product commercialization activities, tech transfers, scale-ups, etc. The qualified person will have a BS degree in a scientific or engineering discipline and at least ten years of aseptic pharmaceutical validation experience in the above-mentioned areas. At least one year of management experience is also required.

The Rocky Mountains are in your backyard. 

100,000

Bachelors Degree in an Engineering discipline or related technical field & previous pharmaceutical industry engineering experience in order to demonstrate an thorough understanding of the technical and engineering practices to design, specify, construct, commission, qualify, and troubleshoot the start up of a manufacturing facility per quality and regulatory standards. (typically gained by 10 – 15 years) Additional experience to include:

• Demonstrated success in the management of multi-million dollar projects adhering to budget and timelines within the pharmaceutical industry.

• Demonstrated knowledge of cGMP, quality systems and regulatory standards.

• Previous experience reporting metrics and KPI’s to leadership teams.

• Previous experience utilizing MS Project.

In addition, you need to demonstrate: the ability to effectively build and maintain relationships in order to motivate and lead a team within a multidisciplinary technical services department; oral and written communication skills; the ability to exhibit flexible thinking while problem solving; and be customer focused. 

Central Sunbelt

Salary: $90,000 + Bonus

Visible QA leadership role overseeing release/reject of Manufacturing Batch records, administration of control and issuance of all documentation to include validation documents, SOP's, PPC, PCR, audit, laboratory documentation and complaint files, line/product inspection functions, and allied areas. We are seeking a person with at least five years of sterile/aseptic QA experience, at least two or three years having been spent in a supervisory capacity. Our client requires a strong range of experience in CAPA, deviations and investigations and a BS degree in an Engineering or Scientific discipline. This position will begin on second shift, 2:30pm to 10:30pm and offers excellent growth potential with one of the top Pharmaceutical firms in the world.

Midwest

Salary: $90-120,000 + Bonus

Two critical positions for a rapidly-growing solid dosage form manufacturing site operated by one of the world's largest drug firms. Responsibilities will include formulation troubleshooting, process development, tech transfers, scale-up and validation activities. Salary is flexible depending on experience level, preferably in the three to ten years range. A BS degree in an Engineering or Scientific discipline is required with preference for Chemical Engineering, Pharmacy, Industrial Pharmacy, etc. Technical services experience with solid dosage forms is required. These are visible positions and will be situated very well for growth as this site continues to expand.

Southcentral US

Salary: $110-130,000 + bonus/stock

This individual will oversee the compliance/audit function for Clinical Trials globally for this major drug firm. We are seeking an individual with significant GCP audit experience for Phase I-IV Trials to include extramural trials at CRO's and internally-conducted as well. Audits include Principal Investigator sites, IRB's, CRO's, Reading Centers and Sponsor. Further expertise required in the areas of compliance evaluations, risk assessments, impact analysis and recommendstions for clinical trials quality initiatives. A BS degree is required along with at least seven years GCP compliance & audit experience working for a MAJOR PHARMACEUTICAL COMPANY

Upper Midwest

Salary: $75-90,000

Growing manufacturer of electromechanical infusion devices, will be responsible for quality systems implementation, FMEA's, coordination of CAPA, deviations, internal auditing, and associated activities. Qualified candidate will have a BS degree minimum with Engineering preferred along with five years experience in medical device quality assurance/systems experience to include 21 CFR 820, ISO 13485and ISO 14971. This company is developing several "next generation" products and this person will be actively involved in those launches.

 

Upper Midwest

Salary: $90-105,000

This visible and critical position is with a leading developer of infusion therapy equipment for cardiology and will be instrumental in the launch of their next generation products. Activities for this individual will include providing direction to development teams on quality issues related to software, electrical and mechanical design elements, Design Controls, Risk Assessment, design validation, maintenance of Design History Files, FMEA and allied areas. A BS degree in an engineering discipline is required with a preference for Electrical or Computer Science backgrounds. This person should also have SME-type expertise and proficiency in application is ISO 14971/13485, IEC 60601-1, Statistical Process Control, etc. Desired experience range would be a minimum of seven years or higher within an electromechanical medical device environment. This position is considered urgent by our client.

GA  Base $60-85, bonus. Relocation available.

Description

The Process Engineer will be responsible for performing process engineering activities in the manufacturing and packaging areas. These activities will primarily be related to process optimization and process/equipment troubleshooting in support of these operations.

Essential Duties/Responsibilities

Experience

Minimum five (5) to eight (8) years experience working as an engineer in a regulated pharmaceutical facility. Minimum two (2) years process engineering experience; finished pharmaceutical manufacturing experience preferred.  Direct experience with cGMPs.

One-three (1-3) years leadership experience (supervisory/management/project management)

INDIANA, BASE $90-100k + BONUS

This person will play a key role in the dramatic expansion of this large solid dose facility for a major US Drug firm. The position will be responsible for performing installation, operational and performance qualification (IQ, OQ, PQ) of critical manufacturing equipment, facilities and utility systems. It will also be responsible for the verification of non-critical equipment, installation of new equipment, re-qualification of existing equipment, etc. Specific areas of expertise required include solid dose blister and bottling equipment, gas/air systems, pure steam, pure water and HVAC with particulate monitoring. The qualified candidate could come from a project engineering or validation engineering background. A BS degree in an engineering or scientific discipline is required along with a minimum of five years experience in the above-mentioned areas. Strong preference for a person with solid dose experience but could possibly consider aseptic processing if the individual has a strong utilities qualification background. This position offers excellent visibility and opportunity to grow dramatically as this site expands.