Senior Director of Manufacturing - Lexington, MA
An oncology-focused biopharmaceutical company located in Lexington, MA,
is seeking a Senior Director of Manufacturing.
SUMMARY
Responsible for all phases of manufacturing and control of products, as
assigned, including clinical supplies. Works closely with Process
Development, Product Development, Quality Assurance, Quality Control,
and other internal and external associates, to sup****t the timely and
cost-effective execution of business and project/program management
plans.
CRITICAL PERFORMANCE
Parenteral Injection to assure product is produced according to
cGMP's
Validation Sup****t & Coordination: Coordinate validation of products at
our contract manufacturing sites in conjunction with Process and
Product Development.
Manufacturing Technical Service: Assure clinical test article is
distributed on time without lost enrollment. Perform investigations
into product manufacturing difficulties as required. Lead any product
manufacturing related OOS investigation
Regulatory Sup****t: Provide manufacturing information to sup****t
regulatory registrations and audits
DUTIES AND RESPONSIBILITIES
Manages the manufacturing contractor operations to assure the timely
delivery of products to the customer to include purchasing, scheduling,
manufacture, packaging, labeling, active pharmaceutical ingredient
(API), raw materials and components, intermediate and finished product
inventories;
Develops or contributes to the development, technical transfer,
validation and approval of do***entation such as specifications,
procedures, manufacturing instructions, tests and controls, as well as
identifying or specifying production equipment and processes to be
utilized;
Contributes to the development of and manages within the budget for the
manufacturing operation for the products assigned;
Plans, schedules, directs and otherwise manages the activities of
associates, contract manufacturers, consultants, and suppliers to
assure development, scale-up, validation, and production plans are met
on time;
Performs as a program management team member or leader on assigned
projects;
Audits and participates in the qualification of suppliers of goods and
services. Responsible for the identification of back up supply vendors
and manufacturers.
Audits inventory records of products and supplies to assure their
accuracy and completeness in sup****t of production planning.
Implements all applicable company policies and procedures;
Responsible for the timely delivery of conforming product at or below
budgeted cost;
Participates in or leads investigations of product or packaging
complaints, damage, defectives batch failures, out-of specification
(OOS) test results, or other re****ts requiring thorough investigation
and re****ting of results along with recommendations for and
implementation of effective corrective or preventive actions;
Responsible for the safety record, and safe practices of self and
internal and external associates;
Responsible for the fair and courteous treatment of all business
contacts, treating customers and associates alike;
Responsible for the training and performance of associates as
appropriate;
Responsible for continually striving to identify and implement
improvements to costs, quality, and service.
REQUIRED
BS/BA degree in Chemistry, Pharmacy, Pharmaceutical Sciences, or
Engineering;
10 years manufacturing experience in the pharmaceutical industry with
supervisory responsibilities;
Good working knowledge of current Good Manufacturing Practices
including their interpretation and application in a manufacturing
environment;
Excellent communication, both written and verbal, planning, organizing
and controlling skills;
Excellent interpersonal skills and ability to work independently as
well as a team member or leader with internal and external associates
at all levels;
High ethical standards and ability to handle sensitive information in a
highly confidential manner.
Must be able to supervise others effectively;
Must be able to be cleared by the Drug Enforcement Agency (DEA) to
handle controlled drugs.
DESIRED
Experience with a variety of manufacturing processes and operations
including synthesis, formulation, filtration, component preparation,
filling, sterilization, lyophilization, labeling and packaging, and
physical testing and inspection methods.
Experience with FDA compliance inspections.
APPLY:
If you are interested in applying for this position, please forward
your Word formatted resume, cover note and salary requirement to
resumes@[EMAIL PROTECTED]
Please include position title in the
subject line of your email. This will ensure your resume is routed to
the correct recruiter as quickly as possible. Only qualified
candidates will be contacted for interviews. Receipt of your resume
will be confirmed if it is sent as an attachment.
REFERRALS:
If you are not interested in the op****tunity for yourself, please
consider referring a colleague or friend. We do have a generous
referral program.
More details are available here:
http://www.workwondersstaffing.net/CandidateResources/Referrals.html
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