Job Title: TRAINING MANAGER
Location: Central Sunbelt
Salary: $100,000 + Bonus
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Extremely visible position at a leading drug manufacturer
involved in oversite of GMP and continuing education training.
This includes manufacturing and quality assurance training
to foster an effective teamwork environment and increases
employee involvement. Must have a BS degree in Education,
Engineering, Business, Human Resources or Life Sciences with
ten years training experience and at least three years in
a leadership/managerial capacity. This person must have pharmaceutical
industry experience so as to be proficient in GMP applications,
ISO standards, etc.
Job Title:
DIRECTOR OF REGULATORY AFFAIRS
Location: New Jersey
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Ground floor opportunity with major branded drug
company. Must have at least five years RA experience in a generic
environment - must have ANDA experience.
Manages
Generic regulatory activities to achieve registration goals
of generic drugs through interactions with Federal agencies
to ensure generic products receive regulatory approval
1. Responsible for the regulatory strategy to register all
generics products in the US, including communication of the
regulatory requirements and providing guidance to the US Regulatory
group on regulatory issues. Negotiates generic drug development
plans with FDA and coordinates responses to questions raised
by FDA in a timely manner during review of data submitted
in support of generic approvals and their supplemental application.
2. Maintains
communication with and between US Regulatory Affairs, Global
Regulatory Affairs, and the FDA/ Generics Drugs Team relating
to obtaining generic drug approvals and maintaining approval
status in the US. Represents US Regulatory Affairs as a member
of the Generics Drug Team for evaluating and selecting development
projects.
3. Responsible
for importation of electronic documentation and assuring imported
documentation is accurate, legible and complete and application
submissions are generated efficiently to meet timeline submissions.
4. Authors
company or departmental standard operating procedures addressing
regulated processes as appropriate. Trains colleagues on US
regulatory requirements as appropriate.
5.
Provides input into strategic planning to achieve global,
regional and departmental goals for generic project approvals
and life-cycle management. Responsible for local and global
cross functional coordination with Technical Operations, Quality,
Regulatory Affairs and to meet pre- and post-approval regulatory
requirements.
Job Title: DIRECTOR OF QUALITY ASSURANCE
Location: Sunbelt
Salary: $140,000 + bonus
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Will be responsible for total oversite of plant-wide
quality operations to include FDA escort, PAI's, documentation,
compliance, audit and lab operations. Must have a demonstrated
track record of management of a quality organization of at least
30 people with experience in topical or solid dosage forms preferred
but not required. A BS degree or higher is required, ASQ certifications
would be a plus. This is a very fast-paced position with a stable,
growing drug firm located in a very moderate cost of living
area.
Job Title: PRODUCTION SUPERVISOR
Location: Southeastern US
Salary: $60,000
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Beautiful southeastern US location, will oversee
fast-paced production environment and department of 30-40
non-union personnal in the mixing/filling of a variety of
dosage forms. Must have a BS degree and at least two/three
years of production supervision experience in an FDA/CGMP
environment, pharmaceutical preferred. This is an off-shift
opportunity to start and allows for ample time off. Position
starts at 7:00 pm to 7:00 am, with a three on, four days off,
four on, three days off shift arrangement.
Job Title: NORTH AMERICA SALES MANAGER
Location: Can Work From Home
Salary: $150,000 total package
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We
are seeking a self-starting NORTH AMERICA SALES MANAGER who
will work from home to lead the start-up of US based sales
and support operations for a Scandinavian medical device company.
The company has developed a unique product utilized for Quality
Assurance in advanced Radiation Therapy that has been enthusiastically
received by some of the leading radiation therapy system vendors.
This is a great ground floor opportunity to be an integral
part of successfully developing and growing this exciting
company in the North American market. No relocation required
as long as there is a major airport easily accessible.
The North America SALES MANAGER will be responsible as follows:
*
Survey and analyze the market situation in the US and Canada
and identify prospective business.
*
Develop and implement a strategy to best cover the North American
market.
*
Develop a network with other companies in the field in order
to identify buyers and to bundle systems with other major
equipment purchases.
*
Plan and make sales calls with prospective buyers.
*
Plan and perform sales on-site demos.
*
Prepare, send out and follow-up on quotations to potential
buyers.
*
Support customers in application, software and hardware issues.
*
Install systems and train customers to use them.
*
Market the products.
*
Plan for and participate in trade shows ( ASTRO, AAPM, etc.
) to generate new leads, demo and explain products to potential
customers.
*
Generate sales forecasts and timely reports to the corporate
sales and marketing manager.
*
Maintain market knowledge and trends, proper self-training,
participate and contribute too company market and product
training and feedback.
The
successful candidate will have significant years of documented
skills in sales in the field of radiation therapy, to preferably
include some software or systems. A wide network in the radiotherapy
field with end users and the main accelerator and other major
equipment producers in the radiotherapy field.
The
ability to be a self-starter with a technical understanding
to be able to support customers both in technical and application
questions is necessary. Good communications skills are essential.
Travel will be in the 50% to 75% range.
Base
salary and incentives are competitive and will be commensurate
with experience. A stock option program will be available.
Benefits are competitive.
CANDIDATES
MUST HAVE EXPERIENCE WITH RADIATION THERAPY EQUIPMENT.
Job Title:
SENIOR SAFETY SPECIALIST
Location: Central Sunbelt
Salary: $90,000 + Bonus
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Requirements: BS Safety or related, MS preferred,
at least five years applicable experience in safety/environmental
engineering, good project leadership skills, stable/clean
employment history. FDA/GMP industry experience preferable
but any manufacturing environment experience considered.
Job Duties: Will be responsible for development and implementation
of programs for plant safety, environmental and transportation
within a drug manufacturing environment. Will act as the Environmental
Proces Leader in support of Environmental Mnagement Systems
and also act as ISO 14001 Deputy Representative. Must have
a BS degree in Safety or a related discipline, MS degree preferred,
and have a good range of experience in ISO 14001, DOT recordkeeping,
EPA, OSHA regulations, compliance documentation, ADA Occupational
Demands, industrial hygiene, and related areas. This is an
extremely visible position offering good advancement potential
with one of America's premier drug firms. Any manufacturing-environment
experience will be considered with preference given to those
people coming from an FDA/CGMP environment.
Job Title: SENIOR AUTOMATION ENGINEER
Location: Central Sunbelt
Salary: $100,000 + Bonus
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Will be responsible for management of automation
projects in support of drug manufacturing in a highly-automated
process environment. Successful candidate will have experience
in varied applications to include valves, pumps, water systems,
utilities, production/packaging equipment, bar coding systems,
and allied areas. It is also important that this individual
have a hands-on approach with some prior experience in PLC
programming to round out his/her experience base. Must have
a BS degree in an Engineering discipline and experience related
to those areas cited above to include Allen Bradley PLC's.
Preferred would be drug or medical device experience but client
will consider candidates without FDA process experience. Additionally,
candidate could be with an operating firm now or an engineering
consulting firm. This company is "Best of Breed"
in the drug industy and this visible position offers excellent
advancement potential.
Job Title: FORMULATION SCIENTIST
Location: Rocky Mountains
Salary: $70-75,000
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Will be responsible for solid dosage form formulation
of pharmaceutical and nutritional products for a leading OTC
products company. Qualified individual will have a BS degree
in an engineering or scientific discipline and at least four
years experience in formulation of nutritional products with
an in-depth knowledge of development of products with multiple
ingredients, vitamins, minerals, uniformity and stability issues.
A pharmaceutical background would be considered if the person
also has the requisite nutritionals expertise. This is a visible
position reporting to the Director of R&D.
Job Title: VALIDATION PROJECT MANAGER
Location: Monmouth County, NJ
Salary: $95,000
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Will be responsible for total project management
of validation efforts for a rapidly-growing drug/device firm
to include process, equipment, cleaning and facilities validation.
Successful candidate should have at least five years of validation
experience in a drug or device environment and a BS degree
in the sciences or engineering. There is a preference for
candidates who have had experience in an aseptic product environment
and/or gamma sterilization methodology. Relocation assistance
is available but candidates commutable to Monmouth County,
NJ would be given first preference.
Job
Title: SENIOR QUALITY ENGINEER
Location: Upper Midwest
Salary: $90,000 + 15% bonus
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This Sr. Supplier Quality Engineer provides
support for activities related to supplier selection and evaluation,
supplier performance, and supplier management program. This
is a major medical device/pharmaceutical company.
Key Responsibilities
• Expected to be a Subject Matter Expert (SME) for site
Supplier Controls and Audit Management in support of Maple
Grove and Plymouth Operations.
• Coordinates and participates in Supplier Audit Program
and ensures external CAPA program is compliant. o Audits supplier
capabilities through direct visits, technical discussions
and Quality System Audits. o Prepares detailed trip reports
and Audit Reports to document findings and observations.
• Distributes monthly and quarterly compliance reports
for the approved vendors list (AVL) and external audit program.
• Communicates quality issues to suppliers as needed
and provides assistance to develop corrective actions to ensure
timely and compliant closure.
• Reviews, understands, and implements updated BSC Policy
changes. Includes incorporation of this information into site
programs through document reviews, protocol reviews, validation
reviews, and training programs.
• Trains suppliers, assessors, and other BSC personnel
on QA specifications for suppliers.
• Supports the development of Supplier Quality infrastructure
by working with management on the development and enhancement
of critical processes and procedures, as well as training
and mentoring less experienced staff.
• Support the day to day activities that take place
for activities related to Alliance partner products
Qualifications
* Bachelor’s degree in a technical engineering field
plus a minimum of 7 years experience auditing in the medical
or pharmaceutical field.
* Strong knowledge of manufacturing operations, quality principles,
and statistics required.
* Certification as a Certified Auditor or Engineer through
ASQ is preferred.
* Must have strong communication skills, self-confidence,
and the will to create win-win scenarios.
* Ability to interact with all levels of the organization
required.
Job
Title: SENIOR QUALITY ENGINEER
Location: New Jersey
Salary: $85,000
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Will be responsible for matters related to Quality inspection,
supplier qualification, validation, stability and documentation.
Should have a good knowledge of CAPA, risk assessment, customer
complaints, tracking and report systems, design controls,
FMEA, SPE, DOE and allied areas. A BS degree is required along
with at least six years of quality engineering experience
within a drug or medical device environment.
Job Title: PRODUCTION SUPERVISOR
Location: New Jersey
Salary: $60,000
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Will provide leadership to a manufacturing unit engaged in
the processing of medical device and pharmaceutical products.
Should have a working knowledge of Continuous Improvement
methodology and Lean Manufacturing concepts. The position
will initially reside on this client's second shift (3:00
pm to 1:00 am) and in addition to base salary would also qualify
for overtime compensation. A BS degree is required with at
least three years of production supervision experience within
a medical device or drug manufacturing environment.
Job
Title: SENIOR PRODUCTION PLANNER
Location: New Jersey
Salary: $90,000
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Will be responsible for generating and maintaining a master
production plan, maintenance of Raw Material and WIP inventories,
analysis of capacity planning studies, development of replenishment
models in light of customer requirements, and allied areas
of Supply Chain activities. Must have a BS degree or higher
and at least five years of production planning experience,
preferably within an FDA-regulated environment, especially
drug or medical device. Should have a good knowledge of SAP
implementation. This is a very visible position with a growing,
publically-traded company.
Job Title: COMPLIANCE AUDITOR
Location: Upper Midwest
Salary: $75-85,000 + 15% bonus
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Responsibilities: - Performs detailed audits of site quality
system processes to confirm compliance with applicable corporate,
site, and external regulations and standards. - Documents
non-conformances and evaluates associated risk. - Serves as
quality system subject matter expert. - Participates in continual
optimization of the audit program, processes, and tools.
Qualifications:
-
Bachelors degree in science, engineering, or other disciplines
applicable to the medical device industry. - Training in auditing
techniques. - ASQ-CQA, ASQ-CBA, or other lead auditor equivalent
certification is required. - Comprehensive working knowledge
of FDA QSR and ISO 13485 required. Knowledge of MDD, CMDR,
RPAL, CFR Part 210/211, CFR Part 11, ISO 14001, and ISO 14971
is highly desirable. - Three to five year’s experience
in quality system auditing, preferably in medical device or
comparable environment. - Experience developing SOPs is highly
desirable. - Proficiency in MS Word and Excel required. MS
Project and Powerpoint highly desirable. - Effective verbal/written
communications, interpersonal, and organizational skills are
essential.
Job Title:
MICROBIOLOGY MANAGER
Location: Central Sunbelt
Salary: $110,000 + 20% Bonus
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Leading drug manufacturer seeks Microbiology Manager with
minimum of a BS degree in the biological sciences and eight
years of pharmaceutical industry experience, three or more
years at a supervisory level and a significant portion of
such having been within a sterile/aseptic product environment.
Specific responsibilities include:
· The incumbent will be responsible for managing the
operation of the microbiology laboratory involved in raw material,
finished product, stability testing, method validations, environmental
and process monitoring · Responsible for compliance
of products to required specifications, and timely testing
to assure product availability; ensuring laboratory compliance
to all company regulatory and compendial standards ·
Managing the microbiology laboratory in the testing and disposition
of critical systems, semi-processed materials and finished
goods, manage the testing of products on stability for all
marketed products. · Managing analytical method transfers
from Product Development and R&D to commercial manufacturing.
· Managing and controlling the laboratory budgets to
meet established objectives · Hiring and training and
development of subordinates · Participating/leading
in products, process and/or complaint investigations ·
Tracking, evaluating and reporting on key quality indicators
· Determining the need for corrective and preventive
actions · Implements corrective and preventive actions
when required · Handling various supervisory responsibilities
including the review and approval of documentation pertaining
to Quality and Manufacturing Systems and processes.
Job Title: PLANT ENGINEERING MANAGER
Location: Central Sunbelt
Salary: $130,000 + Bonus/Stock Ops.
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be responsible for management of plant engineering functions
related to day to day operations and maintenance of building
and utility systems in a heavily automated environment to
include heavy emphasis on Johnson Controls (MVE). This includes
boilers, chillers, pumps, motors, transformers, valves,switches,
thermal piping, medium voltage cable, capacitors, metering
(flow, pressure, temperature, electrical), air compressors,
and allied sectors. A BS Mechanical Engineering is required
along with at least five years supervisory experience within
a drug, medical device or other closely allied FDA/GMP-regulated
environment. Desired candidates will have a good understanding
of plant automation and related validation requirements as
well as a hands-on orientation and ability to relate to and
work with day to day plant maintenance operations personnel.
Reporting to the Vice President Plant Engineering and Facilities,
this is a growth-oriented and very visible position.
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