The following career opportunities were posted this week at DNAjobs.com. For each position, I have listed a short description and a link for more information.

As always, I wish you tremendous success in your searching!

Jason

Head - Regulatory Affairs

(India) Key Responsibilities: To support the ongoing expansion of the company principally into Europe and USA. To establish the Regulatory strategy for the launch in Europe and USA of our clients existing branded generic oncology products. To establish the Regulatory strategy pertaining to development of NCEs. To establish and develop a network of contacts with the relevant regulatory bodies. To keep abreast of developments which impact our clients planned commercialisation of existing and new products. To act as our cklients representative in external negotiations, government lobbying and conferences. To direct all worldwide regulatory activities. This will involve both internal management of the Regulatory Teams in the UK and India and management of any outsourced regulatory work. Interface with the relevant managers at Abbott will also be required in preparation for the launch of products in the US.

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V.P. Medical Director

(US-Massachusetts) Your responsibilities will be numerous in this hands on position. Two (2) positions exist! You will report to, and work closely with the Sr. Vice President of Medical Affairs to plan, direct and oversee clinical studies intended for FDA and foreign regulatory submission. Other duties include: providing clinical expertise and leadership to the company, design, coordinate and finalize clinical research protocols, consent forms, protocol amendments, and CRFs for assigned project(s), establish and maintain relationships with FDA medical staff, consult with Investigators on exceptions to eligibility or deviations from protocols, be responsible for ensuring the successful and timely recruitment of clinical research study participants, review, finalize, and update Investigator Brochures, finalize drug supply forecasts and study drug distribution plans. Requirements: 3-5 years experience overseeing Clinical Trial Activity is necessary.

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Senior Biostatistician

(US-Massachusetts) The Senior Biostatistician will support clinical trial activities in accordance with industry standards for research, and relevant regulations and guidance documents. It is expected that the Senior Biostatistician will be able to work independently. RESPONSIBILITIES: A large portion of effort will be directed to oversight of biostatistical services provided by clinical CROs. An understanding of industry standards for data management procedures used to collect, compile, and present clinical data is required. Responsibilities will include activities that support the planning, analysis, review, and interpretation of clinical data sets from research projects and protocols conducted by the clinical research group. Activities will include, but are not limited to, working with study team members on pre-study planning, protocol development (in particular, the statistical section of the protocol including sample size/power calculations), Statistical Analysis Plan preparation/review, oversight of the biostatistical activities of contractors and contract research organizations (CRO), data quality reviews, and review of tables/listings/figures and clinical study reports.

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Director Medical Affairs

(US-Massachusetts) You will manage a growing department providing vision, leadership and mentoring for Director Medical Affairs department staff. RESPONSIBILITIES: This highly visible Director is responsible for successful management and efficient and effective functioning of the department; oversight of departmental hiring and training; coordination and execution of projects involving clinical monitoring, medical writing, and safety and surveillance; client interactions; evaluation of new processes and methods; achievement of departmental corporate goals and objectives; develop working relationships with sponsors; manage personnel resourcing; implement and revise standard processes; provide drug development strategy; provide medical monitoring; participate in / attend FDA meetings; Occasional travel may be required. Requirements: M.D. and minimum 5 years experience including 2 years management experience; Be familiar with the basic principles of drug development; Strong technical skills in medical writing, protocol development, clinical research and project management; A demonstrated ability to manage projects and staff; strong interpersonal skills.

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Director of Business Development

(US-Massachusetts) Reporting: The Director, Business Development will report to the Vice President, Business Development. Essential Job Function: To represent the COMPANY in interactions with pharmaceutical companies, biotechnology firms and academic organizations in pursuing opportunities for in-licensing and out-licensing products or technologies for development and commercialization. Individual Responsibilities: Collaborate in the development and execution of a comprehensive business development program to identify potential business partners and promising alliances. Utilize a strong knowledge of the pharmaceutical and biotechnology industries to identify, investigate and assess corporate partnering opportunities, and initiate discussions pertaining to both in-licensing and out-licensing opportunities. Foster relationships with pharmaceutical companies, biotech companies and academic organizations by providing relevant information to interested parties, arranging meetings and facilitating technical discussions between company representatives.

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Associate Director of Clinical Monitoring

(US-Massachusetts) RESPONSIBILITIES: The Associate Director of Clinical Monitoring will direct a growing department providing vision, leadership and mentoring for department staff. This is a highly visible position and is responsible for: successful management and efficient and effective functioning of the department; successful coordination and execution of projects involving clinical monitoring; interdepartmental collaboration; interaction with clients; achievement of departmental goals and objectives; Develop and maintain departmental budget; Develop sponsor contracts and budgets; Implement and revise standard processes and procedures; Manage timelines, deliverables, and scheduling; Manage personnel resourcing; Participate in internal, client/sponsor, scientific and other presentations as required. Travel up to 25% may be required.

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Quality Control Bioassay/Virology Scientist

(US-Massachusetts) An opportunity exists to join a rapidly expanding, financially stable company. Your track record of success in leading clinical programs will now provide you with the opportunity to develop and implement early clinical development programs to include the clinical pharmacology component. Your experience will allow you to manage this early clinical stage product through the clinical/regulatory process and into approval. You will be the recognized expert in all clinical pharmacology issues/questions. Your qualifications must be a PhD / PharmD with significant experience in a clinical pharmacology related discipline. Global project management experience is a must as well as budgetary/financial responsibilities. A track record of leading a pharmaceutical development is a necessity.

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Clinical Program Manager

(US-Massachusetts) The (Sr) Clinical Program Manager works within the Department of Clinical Operations to manage clinical studies that are designed to establish the safety and effectiveness of Company's products. This person initially will focus on early clinical development, but will have the ability to bring one or more of these products to Phase III development, as necessary. Skills required include study planning and training, study initiation, study management, and completion of final clinical study reports. Liaison with potential clinical investigators and management of Contract Research Organizations and other clinical resources is a significant aspect of this position. Responsibilities: Develop clinical development plans and study timelines. Participate in the development of clinical protocols, Investigator Brochures, consent forms, training material, and other clinical documents, as required by the project.

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Contract Manufacturing Manager

(US-Massachusetts) Supervise the preparation of process validation protocol and the completion of its execution. Develop processes and procedures to meet all US and EU regulatory and corporate partner(s) special in-house requirements. Train contract manufacturer’s personnel in these additional requirements, processes and procedures. Work with the package engineer to define new devices (e.g. syringes) or components. Trouble-shoot problematic process areas and find solutions to these areas. Support contract manufacturer’s personnel in preparing and validating cleaning and sanitization procedures. Work with contract manufacturer to increase the productivity and capacity of the plant. Supervise the preparation of the stability protocols and work with the testing laboratories to timely execute all protocols. Define equipment requirements for manufacturing. Interact with equipment vendors to ensure that the most suitable equipment is selected and trouble-shoot to resolve any equipment problems.

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Vice President -Regulatory Affairs

(US-Massachusetts) MISSION STATEMENT: To develop, support and manage regulatory strategies. To review and approve data packages for product candidates to ensure completeness, accuracy and validity of data in support of regulatory applications. RESPONSIBILITIES: Anticipate consequences and assess impact of new or revised worldwide regulations and guidelines on the company’s strategies. Review and approve key segments of regulatory submissions. Represent the company and effectively participate with senior level representatives of regulatory agencies worldwide. Effectively interact with senior company management to influence direction of the Regulatory Affairs group and associated company efforts. Communicate to senior management regulatory strategic & tactical plans to achieve company goals. Act as recognized leader in the drug development process with comprehensive and business knowledge in a variety of product areas.

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Director Protein Formulation

(US-Massachusetts) Are you looking for an opportunity that provides you with influence, impact, visibility and responsibility? If so, read on! Reporting to the Vice President, the qualified candidate will lead and manage the BioFormulations Development Group. This group is responsible for developing recombinant protein formulations suitable for commercial product use. This group interfaces with multiple Research and Development teams and also supports physical chemical characterization of candidate molecules, as well as early formulations, used during initial preclinical studies. Additionally, the group’s responsibilities entail profiling the physical chemical properties of lead formulation candidates and identifying potential development challenges in terms of stability as well as bioavailability and delivery. This group plays a lead role in the formulation selection process working in close collaboration with the Science, Clinical Research, Manufacturing Support, Quality and Regulatory teams.

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Analytical Chemist

(US-Massachusetts) Keys: Supervisory experience, small molecules, method development, Mass Spec. If you possess these attributes, you should read on! Responsibilities: An opportunity currently exists to manage and lead a team of scientists (10-15) focused on analytical method development and HT characterization of synthesis products. You and your group will work closely with peers from synthetic chemistry and parallel synthesis operations to assure an efficient process and productive work flow. Education: PhD with Post-Doc. Requirements: You should have 10+ years of biotech/pharma industry experience. A strong background in separation science or mass spectroscopy combined with quality control/characterization of small organic molecules.

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Microbiologist

(US-New Jersey) Our client is the world's most comprehensive, broadly based manufacturer of health care products. Their products include services for the consumer, pharmaceutical and medical device markets. They provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life. Presently, they are in need of a Microbiologist. This position is located in Skillman, NJ. Major Duties and Responsibilities: -Preservative Efficacy Challenge Testing -Microbial Content Testing -Microorganism Identification using Gram Stain plus VITEK and API -Maintenance & Calibration of Instruments Job Requirements: -High energy level & strong organization skills -Independent working skills -Aseptic Technique Measures for Skills/Knowledge: -Consumer or Pharmaceutical Microbiology Laboratory Experience (min.1-2yrs, optimal -3yrs).

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Director of Regulatory Affairs

(US-Massachusetts) Reporting to the Vice President, Clinical and Regulatory Affairs, you will develop and implement regulatory strategies for product development and approval; be responsible for regulatory documents, submission, and compliance issues; represent the company with domestic and international regulatory authorities; and provide regulatory support for various departments, projects, and teams/committees. RESPONSIBILITIES: Direct regulatory responsibility for company products. In conjunction with the VP, Clinical and Regulatory Affairs, develop and execute creative product development and regulatory strategies, including risk assessments, regarding submissions and compliance issues. Provide clear and valid regulatory guidance to company personnel throughout the research and development process. In conjunction with the VP, Clinical and Regulatory Affairs, direct and prepare clear and effective submissions and presentations for regulatory agencies, senior management and external parties.

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Medicinal Chemists - Research Associates

(US-Massachusetts) Job Description: A productive synthetic chemist, well-versed in modern synthetic methods and spectroscopy techniques, who will work closely with scientists in medicinal chemistry to plan and execute syntheses of compounds required in lead identification and lead optimization programs. The successful candidate will devise and execute synthetic routes to agreed target compounds; as well as monitor and evaluate new synthetic technologies (e.g. parallel synthesis and purification techniques). Record work in laboratory notebooks and present progress at chemistry group and project team meetings. Maintain current knowledge of synthetic methodology through literature reading and meeting attendance. Requirements: 5 years of synthesis experience, preferably in a biotechnology or pharmaceutical industry setting. Demonstrated experience executing multi-step organic syntheses and familiarity with application of modern spectroscopic and separations techniques are requisites.

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Regulatory Affairs Associate

(US-Massachusetts) Provide Regulatory guidance, strategic advice and contribute to a Regulatory project team planning on CMC issues. Handles all aspects of CMC-related activities for assigned biological development project. RESPONSIBILITIES: Review and assessment of all CMC documents for consistency Accuracy and conformance with all regulatory requirements; Identification of content, responsibility and timing of CMC documents for regulatory submissions; Coordinating and monitoring the progress of all CMC regulatory submissions; Providing regulatory guidance for CMC issues, processes and templates by working closely with Manufacturing and Quality through all phases of drug development; defining current regulatory requirements for technical submission (INDs, CTXs, BLAs, and DMFs); Directly interacting with regulatory authorities(internal) and Manufacturing and Quality (external) on CMC issues requiring agency feedback; and participating in pre-approval inspection activities.

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Protein Formulation Scientist

(US-Massachusetts) Would you like to be involved in developing the next generation of drug delivery technology? An opportunity currently exists if your experience is in protein and parenterals. Read on! RESPONSIBILITIES: (1) Develop novel formulations and processes for concentrated protein and small molecule parenteral drugs, (2)Design and perform stability studies of drug formulations, (3) Transfer formulation processes to contract filling/packaging vendors. ORGANIZATIONAL ACTIVITIES: (1) Establish stability study program (2) Formalize and document process procedures QUALIFICATIONS AND SKILLS: (1) Formulation development, (2) Research new formulation technologies for concentrated drugs, (3) Develop new formulation processes, (4) Design stability studies, (5) Participate in development of analytical assays. EXPERIENCE / EDUCATION: 5+ years relevant work with diverse concentrated complex proteins combined with GLP, GMP and CMC work experience. Ph.D. in Pharmaceutical Sciences.

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Medical Writer

(US-Massachusetts) Two positions exist! DESCRIPTION: The medical writer will be an active member of the clinical implementation team. The qualified candidate is involved early in the clinical trial process by reviewing and editing clinical study protocols and preparing report prototypes. The medical writer is responsible for driving the clinical study report writing process. He/She also assists Clinical Development in preparation and finalization of other clinical documents (i.e., clinical sections of regulatory submissions, safety summaries, investigator brochures, publications, presentations) as appropriate. QUALIFICATIONS: Minimum of a Bachelor’s degree in the sciences (Masters preferred) and at least three years medical writing experience. Must be proficient in writing protocols, clinical study reports, and documents for global regulatory submissions. Familiarity with CFR and ICH guidelines.

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Director of Facilities

(US-Massachusetts) Responsibilities: Direct the daily operations and management of a growing biotechnology facility, including buildings, campus, safety and services. Actively ensure Company compliance with all permits, licensure, GCP, GLP, GMP and safety regulations. Create, drive, support and foster an environment that matches Company philosophy. Drive the development of current as well as future facilities, buildings, services and environment. Direct the management of internal services and vendors. Strategically drive and source Facility Maintenance functions as needed through a combination of staff, contractors, leased employees and temps. Education: Bachelor’s degree required, additional certifications a plus. Requirements: Minimum of 10 – 15 years of facilities experience, including at least 5 years in GLP, GCP and GMP environment and at least 5 years management experience. Biopharmaceutical or biotech background required.

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Director Drug Safety

(US-Massachusetts) The Medical Director, Clinical Safety will be responsible for insuring consistency of safety assessment, analysis and reporting across the company's clinical development programs. In addition, you will, in conjunction with Reg.Affairs, insure compliance with regulatory reporting requirements for clinical trials. He/she will work closely with the program specific Medical Directors in proactively assessing and addressing safety issues for each of the clinical development programs. This position will manage and develop a staff of Clinical Safety Managers. RESPONSIBILITIES: Manage Clinical Safety Group, Insuring adequacy of training, job performance and career development. Will provide oversight to insure completeness and timeliness of reporting for both expedited as well as non-expedited serious adverse events. Maintain electronic SAE database (including compliance with regulatory reporting requirements.

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Medical Science Liason Manager

(US-Massachusetts) The Manager of Medical Science Liaisons (MSLs) will be responsible for managing all activities of the field-based MSL team, providing scientific information to requesting medical professionals, acting as a company liaison for Investigator Initiated Clinical Research Studies (IIS), and supporting third party reimbursement efforts. RESPONSIBILITIES: Directing the activities of MSLs including training, education and career development. In collaboration with Drug Information Services, prepare and update master portfolio of available scientific information for distribution by MSL’s to medical professionals. Following up with and assisting health professionals interested in investigator initiated studies. Assuming a central role in preparing for the launch of a new product including strategic input and development of relevant materials for the MSL team. Establishing and maintaining relationships with key opinion leaders at targeted Academic Centers, Medical Directors and Managed Care Organizations.

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Pharmacy Manager

(US-Colorado-Denver) Description: Assist the Pharmacy Director in directing, planning and coordinating the activities, functions and operations of Pharmacy Services. Manages daily pharmacy operations; supervises pharmacists and technicians, and coordinates the provision of pharmacy services. Required: Bachelor of science degree in Pharmacy or a Doctor of Pharmacy (PharmD) degree from an accredited College of Pharmacy. Minimum of 3 years experience as a Hospital Pharmacist or related field within Pharmacy. Masters degree in business or healthcare field, clinical pharmacy residency and Management/supervisory experience preferred. Licensed by the State of Colorado as a Pharmacist This is a full-time position. The working hours are 7am - 3:30pm. Their benefit program is designed to make a difference for employees and their families. Those benefits include: *Medical Insurance *Dental Insurance *Vision *Long Term Disability Insurance *Life and Accidental Death and Dismemberment Insurance (AD&D) *Dependent Life and AD&D *Health care and dependent care reimbursement accounts *Group legal plan *Employee assistance program *Retirement Plan - 401(a) with a generous employer match *Employee 403 (b) Retirement Plan *Paid Vacation and Holidays: Paid Leave Time (PLT).

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Plant Manager

(US-Missouri-St. Louis) Plans, directs, coordinates and manages plant operations within the scope of objectives and policies established by corporate management. Responsible for operational results of a state of the art pharmaceutical manufacturing facility. JOB SPECIFICATIONS: Hands-on experience with coating, compressing, and packaging tablets required. Experience with granulation and liquids manufacturing a plus. Experience with state-of-the-art methods including automated high-speed equipment. Experience supervising packaging and manufacturing in a union environment with demonstrated success at meeting productivity requirements. Excellent management and leadership skills, including superior organization, strong interpersonal skills at all levels, and ability to schedule equipment and people. Excellent oral and written communication skills. Demonstrated problem-solving skill through difficult and complex problems.

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Industrial Engineer

(US-Missouri-St. Louis) Industrial Engineer Responsible to provide leadership, coordination and industrial support to the changing and growing environment for all operations. Will provide timely manufacturing and packaging capacity and efficient utilization of equipment/facilities and reducing operational costs for all company Divisions. Indentifies opportunities and assist Packaging and Manufacturing departments in implementation and/or support of cost savings projects and ideas to increase capacity and improve plant operations. Establish and maintain production standards, equipment capacities and layouts to justify projects including ROI's. Perform ergonomic reviews, ensure CGMP Compliance, cost estimating and cost control, etc. Requirements: BSIE required. 5 years minimum pharmaceutical experience performing IE functions in manufacturing, packaging or facility related areas focusing on problem solving and solution design issues in these areas.

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VP/Sr. Director Formulations

(US-North Carolina-Wilmington/Fayetteville) President/Sr. Director, Formulations To provide scientific and administrative leadership to the Formulations Development Laboratory. This will include: Ensuring timely and efficient pre-formulation and formulation development of drug delivery products for client companies and internal R&D programs. Establishing and maintaining effective communication between the lab, sales and customers. Responsible for all lab-related customer interfaces. Overseeing continuous improvement initiatives, which includes analyzing the lab’s production capabilities and, as necessary, redefining goals and objectives to improve quality, efficiency, customer service and profitability. Ensuring the financial, operating, and strategic success of FDL. Will develop and implement budgets and goals in support of business objectives. Providing leadership, managerial skill, flexibility and a sense of opportunity for all personnel. Qualifications: Ph.D. in Pharmaceutics.

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