The Clinical Supply Manager is responsible for planning, packaging, labeling and distribution of investigational medicinal product to support Vertex clinical study protocols. This person delivers on independent activities and acts as the primary Supply Chain contact on working teams and with key contract manufacturing/logistics suppliers.

Key Responsibilities
- Ownership of Clinical Supply Chain activities including planning, labeling, packaging and distribution of Investigational Medicinal Product for multiple projects.
- Acts as primary point of contact with contract manufacturing partners.
- Forecasts supply needs in conjunction with Clinical and CMC colleagues.
- Interacts with Finance to develop budgets and manage costs for clinical supply activities.
- Supports the Supply Chain team’s development of global supply and procurement strategies including vendor selection
- Utilizes appropriate software and IT systems to effectively manage key project activities.
 
Technical and Communicative Skills
- Direct Clinical Supply management experience using contract manufacturing companies strongly preferred.
- Work experience must include some of the following: drug development, project management, clinical trials management, pharmaceutical manufacturing/packaging.
- Demonstrated ability to collaborate with other functional areas such as Pharmaceutical Development, Technical Operations, Clinical Operations, Regulatory, Quality Assurance/Control .
- Working knowledge of regulations relating to clinical labeling, packaging and distribution activities (cGMP, GCP).
- Demonstrated excellence in project management and managing, tracking, and measuring project progress.
- Displays proven effectiveness in managing customer expectations and influencing others.
- Knowledge of Interactive Voice/Web response systems for use in clinical studies.

Minimum Qualifications
- M.S. and 3-5 years of experience working in a Manufacturing or Pharmaceutical Environment, 1-2 years of which are in a Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in a Biotech, Pharmaceutical, or CRO company
- B.S. and 5-7 years of experience working in a Manufacturing or Pharmaceutical Environment, 2-3 years of which are in a Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in a Biotech, Pharmaceutical, or CRO company

Preferred Qualification
- Demonstrated excellence in project management and managing, tracking, and measuring project progress

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

Constellation Pharmaceuticals leverages insights from the rapidly expanding field of epigenetics to discover and develop small molecule therapeutics for the treatment of cancer, inflammatory/immunologic disorders and other diseases. Research here and by others has shown that abnormal epigenetic regulation of gene expression contributes to many different diseases. Our innovative product discovery engine targets both the enzymes that modify the dynamic structure of chromatin and other proteins that interact with chromatin to control gene expression.

Scientist – Biology

The Department of Biology seeks a motivated and experienced Scientist specialized in mass spectrometry based proteomic methodologies and proteomics data analyses. These techniques are used to quantitatively assess changes in protein levels and post-translational modification states within a given proteome derived from various cellular contexts or in response to genetic and pharmacological manipulation of biological systems.  The position requires expertise in proteomics, preferentially some experience with chromatin/histones and a passion to do high quality scientific research in a collaborative, goal-oriented and fast-paced team environment.

Responsibilities

• Primarily responsible to apply a proteomics approach for the analysis of key molecular epigenetic processes in a large number of biological contexts, mainly focused on oncology models.
• Contribute to the biomarker discovery in biology by applying our proteomics approach to identify key changes chromatin post-translational modifications in various pharmacological settings.
• Contribute to the Epigenetics Discovery efforts by applying a proteomics approach to identify protein interaction partners and post-translational modifications thereof.
• Active interaction and collaboration with other project team scientists.

Requirements:

• Ph.D. in life sciences with focus on mass spectrometry and proteomics including data analysis with 1-5 years of work experience
• Experience with state of the art nanoflow liquid chromatography-tandem mass spectrometry for the analysis of complex protein mixtures
• Experience with commonly used mass spectrometry and proteomics analysis software
• Ability to quickly adopt Constellation’s proteomics analysis paradigm and cooperate with our IT team to further develop our proteomics analyses capabilities.

• The ideal candidate already possesses experience with comparative, quantitative proteomics to characterize post-translational modifications of histones using SILAC and bottom-up approaches
• The preferred candidate has some understanding of chromatin biology and cancer pathways
• Flexibility to work across diverse areas, ability to develop and evaluate novel assays for a wide variety of biological/phenotypic endpoints
• Strong oral and written communication skills, keeping good scientific records, writing reports and giving updates at team meetings is required

• Detail oriented, self-motivated, resourceful, with the ability and desire to work in a challenging dynamic environment under tight deadlines is required
• JOB CODE - S-PT

Constellation Pharmaceuticals is an Equal Opportunity Employer and a participant in E-Verify, and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.

If you are interested in joining Constellation’s team please submit your resume to the following address: careers@constellationpharma.com

Harvard Clinical Research Institute is a leading Academic Research Organization in the design and management of full-service clinical trials.  Working in close collaboration with the Harvard Medical School, our mission is to improve health and quality of life by collaborating with academic and industry partners to conduct high quality clinical research in a professionally nurturing and world-class academic environment.

ABOUT THE POSITION:

The Research Coordinator will provide medical writing support and will be primarily responsible for review of medical literature, preparation of tables, figures and drafts of manuscripts and abstracts.

Primary Duties and Responsibilities:

1. Medical literature searches with Medline on various cardiology topics, retrieval of publications from Countway Medical Library, abstraction of data from literature, and Endnote library preparation.
2. Statistical analysis.
3. Preparation of publication quality tables and figures.  Format and prepare draft shells for manuscript and abstract submission.
4. Other duties assigned.

Requirements:

1. BS/BA degree.
2. Good medical understanding.
3. Proficiency with PCs and windows-based software, including Word, Excel and Endnote.
4. Careful attention to detail & concern for quality.
5. Excellent organizational skills and ability to prioritize a variety of tasks.
6. Excellent interpersonal, oral and written communication skills.
7. Comply with hospital regulatory requirements, FDA/GCP guidelines, and HIPAA regulations.

Repligen BioProcessing is a business unit focused on providing Upstream (Cell Culture) and Downstream (Purification) products and services for the biopharmaceutical and life sciences marketplace.

We are looking for an experienced product manager to develop and implement long term strategic plans as well as complimentary annual business plans that include defined actions for increasing product revenue and contribution.  This work will be completed for each of the company’s major “product market pairs” and includes conducting market application needs analysis and developing gap analyses based on comparing current company and competitive products to the defined market need.  This individual is expected to work collaboratively across the Repligen organization and build effective relationships that advance product development and product sales.

Duties and responsibilities

Market Development

• Demonstrate true understanding of the upstream cell culture (CCI) marketplace
• Lead Repligen’s product positioning, sales and marketing in the CCI market space
• Own the development, review and execution of strategic and annual business plans for each of the CCI products
• Identify new product and acquisition opportunities
• Responsible for OEM & strategic channel account sales

Sales Revenues

• Forecast and report sales revenues by product type
• Develop a key account plan that appropriately directs and deploys field sales resources
•  Make joint sales calls with the sales managers as required to close potential accounts
• Directly own the management and development of key accounts
• Become Repligen’s internal customer advocate ensuring that customers receive required technical and product support

Marketing Strategies

• Develop and execute strategic marketing programs including collateral, conferences and web that will create awareness, generate leads and secure sales

Technology Integrator

• Develop a strong reputation for technical competence and a rapport with our customers and the market place in general
• Interface with sales, R&D and applications specialist to address CCI product and technology issues
• Identify and develop external KOL’s that can be called upon to support our business
• Develop and train our field sales personnel and be a technical resource to our external customer base

The successful candidate will demonstrate:

•  Leadership ability to work across organizations while also demonstrating flexibility in interacting with individuals at all levels and business disciplines
• The strength and fortitude to be the customer and market advocate to the internal organization
• Proven ability to develop and manage project plans that deliver product information and marketing solutions to address the prioritized elements of the “gap” analysis
  • Work with R&D to ensure alignment exists on R&D project plans and priorities
  • Effectively manage resources
  • Interface with Business and Market Development to ensure that the appropriate product marketing literature, sales collateral, website and PR materials are correct and executed to plan
  • Champion and support Manufacturing and QA/QC operations in the development and implementation of market oriented cost reduction programs and QA program standardsCapability of implementing an effective customer service function
• Capability of implementing an effective customer service function

• Administration for order entry and fulfillment
• Operations for product delivery, inventory management and QA response to customer complaints
• System for providing customers with technical support

Qualifications/Requirements

• Bachelor’s degree in biology or related discipline required
• A minimum of 3 years’ experience in the biopharmaceutical or life science industries
• Previous experience in sales and marketing, commercial product management and/or project management practices preferred
• Skilled in analytical assessment and problem solving
• Proven ability to build mutually beneficial trusting relationships with customers, suppliers and internal business partners
• Strong organizational skills
• Excellent verbal and written communication skills

Please send cover letter with a resume in either MS Word or PDF format to:  resumes@repligen.com

Support ongoing Quality System (GXP) infrastructure build as well as managing new systems once developed including but not limited to i) managing the training program, ii) assisting with completion of required SOPs, iii) managing the annual audit program iv) conducting GXP audits, including but not limited to clinical documentation audits, internal compliance audits and external vendor audits as deemed necessary.  While main focus of efforts will be to support the GCP activities at EnVivo, support for the review of batch records, CoAs, and material release may also be required as work load dictates. 

Requirements

BS/BA degree in life sciences or equivalent with 7 years in GXP related positions in biotech/pharma industry is required.

Knowledge of current GXPs, including GCP, cGMP and GLP is required.  Good communication skills, both oral and written are necessary. Ability to apply regulations to real world scenarios and ongoing drug development tasks in a manner to support efforts and colleagues is needed. Previous experience with auditing of clinical documentation, handling deviations and CAPA reports, and managing compliance documentation is required.  

A career with Randstad at Millennium Pharmaceuticals, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time.

ADCETRIS is a late-stage, multi-faceted project with approvals currently in the US and Europe for r/r HL and sALCL. This project requires a complex matrix of global regulatory professionals and significant regulatory support to successfully fulfill established and projected business needs. The continuing ability of the ADCETRIS GRL to ensure that the RST can deliver to corporate expectations is, in part, based on the support provided by a full-time, experienced Global Regulatory Strategy Group (GRSG) Manager.  Since the current range of regulatory activities is extremely broad for this project, the GRSG Manager would likely be involved in ADCETRIS activities to various degrees based on their level of regulatory and drug development experience. Ideally, an individual with regulatory affairs experience would be best suited to the ADCETRIS project in order to maximally plan for success.

Proposed Scope of Work

The ADCETRIS GRSG Manager would be expected to provide support for the following ongoing and planned activities for the current and next 2 fiscal years:

• RST weekly meetings support involving the preparation of agendas, minutes, follow-up on action items
• RA Department support including, but not limited to, generation of RA cross-area monthly RA Dashboard,  bi-monthly Regulatory Submission Report update management, monthly Regulatory Project Goals management, annual and ad hoc RA Project Resourcing and Budget Planning, EU and ROW Health Authority Commitments tracking, Regulatory Development Plans for ADCETRIS and CD30 CDx, etc.
• SGEN and Ventana Alliance support for Joint SGEN Regulatory Subteam monthly meetings (including agendas, minutes, co-chairing, etc), Alliance Team Meetings (as needed), Alliance support for MPI CDx strategic input, and coordination of certain key SGEN-related activities such as DSURs/SUSARs, and depending upon level of regulatory experience review of documents.
• EU MA support for the monitoring and communications regarding the nine clinical post-marketing commitments, and the regulatory review of PSURs, Annual Report, and health care reimbursement documents
• J-NDA and Emerging Markets marketing applications for the r/r HL and sALCL for activities ranging from dossier preparation assistance, dossier defense support, and health care reimbursement support
• Life Cycle Management Activities Support for the ongoing trials in CTCL, FL HL, and Pediatrics; planned EU Re-Treatment and AETHERA (HL maintenance in post-ASCT high-risk patients) EU NSA interactions
• EU, J-NDA, and Emerging Markets marketing applications for AETHERA for dossier preparation assistance and coordination of regulatory review of selected documents
• Maintain RA and GRSG SharePoint site and W drive – uploading meeting minutes, presentations, etc
• Help with slides for Core Team, internal governance committees
• Assist with updating Regulatory Development Plan
• Life Cycle Management Activities Support
• Assist with regulatory research on particular topics
• Assist with any additional pediatric plans or orphan drug applications
• Annual & Ad Hoc RA Project Resourcing & Budget Planning
• Assist with regulatory-focused alliance management activities with SGEN and Ventana

A career with Randstad at Millennium Pharmaceuticals, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time.

ADCETRIS is a late-stage, multi-faceted project with approvals currently in the US and Europe for r/r HL and sALCL. This project requires a complex matrix of global regulatory professionals and significant regulatory support to successfully fulfill established and projected business needs. The continuing ability of the ADCETRIS GRL to ensure that the RST can deliver to corporate expectations is, in part, based on the support provided by a full-time, experienced Global Regulatory Strategy Group (GRSG) Manager.  Since the current range of regulatory activities is extremely broad for this project, the GRSG Manager would likely be involved in ADCETRIS activities to various degrees based on their level of regulatory and drug development experience. Ideally, an individual with regulatory affairs experience would be best suited to the ADCETRIS project in order to maximally plan for success.

Proposed Scope of Work

The ADCETRIS GRSG Manager would be expected to provide support for the following ongoing and planned activities for the current and next 2 fiscal years:

• RST weekly meetings support involving the preparation of agendas, minutes, follow-up on action items
• RA Department support including, but not limited to, generation of RA cross-area monthly RA Dashboard,  bi-monthly Regulatory Submission Report update management, monthly Regulatory Project Goals management, annual and ad hoc RA Project Resourcing and Budget Planning, EU and ROW Health Authority Commitments tracking, Regulatory Development Plans for ADCETRIS and CD30 CDx, etc.
• SGEN and Ventana Alliance support for Joint SGEN Regulatory Subteam monthly meetings (including agendas, minutes, co-chairing, etc), Alliance Team Meetings (as needed), Alliance support for MPI CDx strategic input, and coordination of certain key SGEN-related activities such as DSURs/SUSARs, and depending upon level of regulatory experience review of documents.
• EU MA support for the monitoring and communications regarding the nine clinical post-marketing commitments, and the regulatory review of PSURs, Annual Report, and health care reimbursement documents
• J-NDA and Emerging Markets marketing applications for the r/r HL and sALCL for activities ranging from dossier preparation assistance, dossier defense support, and health care reimbursement support
• Life Cycle Management Activities Support for the ongoing trials in CTCL, FL HL, and Pediatrics; planned EU Re-Treatment and AETHERA (HL maintenance in post-ASCT high-risk patients) EU NSA interactions
• EU, J-NDA, and Emerging Markets marketing applications for AETHERA for dossier preparation assistance and coordination of regulatory review of selected documents
• Maintain RA and GRSG SharePoint site and W drive – uploading meeting minutes, presentations, etc
• Help with slides for Core Team, internal governance committees
• Assist with updating Regulatory Development Plan
• Life Cycle Management Activities Support
• Assist with regulatory research on particular topics
• Assist with any additional pediatric plans or orphan drug applications
• Annual & Ad Hoc RA Project Resourcing & Budget Planning
• Assist with regulatory-focused alliance management activities with SGEN and Ventana

A career with Randstad at Millennium Pharmaceuticals, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time.

Regulatory Affairs – CMC Small Molecule

Position Summary: This individual is expected to contribute to the development and implementation of CMC regulatory strategy for products in development with minimal supervision as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs. This person will serve as the regulatory CMC representative on relevant project teams, and as the regulatory CMC contact with FDA and other regulatory authorities for CMC related issues.


Duties and Responsibilities:
• Monitor changes to development plans and design globally compliant CMC regulatory strategy for products at all stages of development with minimal supervision
• Drive global CMC regulatory submission activities (IND, CTA, NDA, BLA) and health authority interactions (meeting requests and briefing documents)
• Represent Regulatory Affairs at various project team and working group meetings
• Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
• Interface with Millennium Quality systems in compliance with Corporate SOPs.
• Evaluate analytical procedures, specifications documents, comparability protocols, validation protocols, and stability protocols for consistency with relevant global regulations and guidelines.
• Ensure the quality and content of all submissions to health authorities
• Act as direct point of contact with FDA and other regulatory authorities for CMC related issues


Qualifications:
Experience: A minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful. Must have a minimum of 5-7 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry.

Other: Demonstrate knowledge of drug development process and knowledge of FDA, EU, Canada, and ROW regulatory requirements. Demonstrated project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).

A career with Randstad at Millennium Pharmaceuticals, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time.

Position Summary: This Senior Manager position is established to play a key role in the planning and management of regulatory submissions to global health authorities. This individual is expected to provide leadership within Regulatory Affairs and all other data generating departments to ensure timely filing and approval of assigned programs.


Duties and Responsibilities:
• Responsible for the implementation and execution of global regulatory strategies
• Represents the function at clinical trial working groups and at the clinical sub-team levels. May represent the function at other sub-teams as assigned
• May represent the regulatory function at the global core team
• May be the regulatory therapeutic representative on the labeling committee
• Accountable for submission of IND’s, CTAs and other major regulatory submissions, including Briefing Packages and Annual Reports to INDs, CTAs, NDAs and BLAs
• Is expected to communicate directly with FDA on most issues and may be the lead regulatory representative at FDA meetings for the assigned products of responsibility

Qualifications:
Experience: A minimum 4-year degree in a scientific or technical discipline; advanced degree preferred. Must have a minimum of 5-7 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry.

Other qualifications: Management experience is a plus. Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements. Knowledge of EU, Canada, ROW and Post-marketing a plus. Direct experience in interacting with regulatory authorities; experience interacting with DDMAC is a plus. Candidates must be able to influence others and demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).

A career with Randstad at Millennium Pharmaceuticals, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time.

Manager, Regulatory Affairs

POSITION
The Submission Manager will be an integral member of the Global Regulatory Dossier Management Group. On a daily basis, the Submission Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, and utilizing a wide array of document management, authoring, and publishing tools. The Submission Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.

DUTIES
Working closely with the Regulatory Leads, the Submission Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management.
Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines.

Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management.

Identify issues that may delay product or project and recommend appropriate action.

Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology.

Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity.

Prepare and maintain templates that meet Regulatory electronic submission standards.

Assist in development and maintenance of our electronic submission capability at Millennium, representing the Regulatory business function on technology teams.

Basic qualifications:
Minimum of 4 years of experience within the pharmaceutical industry and strong submission management and/or project management experience is required. Skill in using desktop applications and proficiency in computer systems and procedures is required.

Preferred qualifications:
Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired. Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired

A career with Randstad at Millennium Pharmaceuticals, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time.

Manager, Regulatory Affairs

POSITION
The Submission Manager will be an integral member of the Global Regulatory Dossier Management Group. On a daily basis, the Submission Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, and utilizing a wide array of document management, authoring, and publishing tools. The Submission Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.

DUTIES
Working closely with the Regulatory Leads, the Submission Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management.
Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines.

Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management.

Identify issues that may delay product or project and recommend appropriate action.

Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology.

Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity.

Prepare and maintain templates that meet Regulatory electronic submission standards.

Assist in development and maintenance of our electronic submission capability at Millennium, representing the Regulatory business function on technology teams.

Basic qualifications:
Minimum of 4 years of experience within the pharmaceutical industry and strong submission management and/or project management experience is required. Skill in using desktop applications and proficiency in computer systems and procedures is required.

Preferred qualifications:
Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired. Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired

Summary:  The primary responsibility will be to provide strategic and operational regulatory expertise and leadership necessary to advance the Company’s drug candidates by championing an organizational culture which promotes actions and behaviors that lead to exceptional performance.  Provides leadership and drives all functional aspects of the global regulatory process to ensure timely filing and approval of new products in accordance with business objectives.  Possess the ability to recognize potential problems and take effective steps to resolve them judiciously.  This candidate must be credible, influential, and respected corporate spokesperson for interaction and negotiations with regulatory authorities and agencies.  Plans, prepares, and manages timelines for all regulatory documentation and regulatory argumentation for submissions including initial Investigational New Drug applications (INDs), IND amendments, New Drug Applications (NDAs), orphan drug designations, meeting requests, special protocol assistance and assessing regulatory requirements for Chemistry, Manufacturing & Controls (CMC), preclinical and clinical submissions as well as programs to assure that all development activities are in compliance with applicable regulations and guidelines.  Able to lead project teams and sub teams for the planning of activities needed to meet long term corporate objectives.

Responsibilities:  Include but are not limited to the following:

Direct role in drafting, reviewing, and administering regulatory strategy and policy throughout the drug development process.  Expectations will be to effectively negotiate with regulatory authorities.  The incumbent will ensure that the quality and content of submissions will lead to successful and timely approval of regulatory application.

  - Contribute to the development of biopharmaceutical products by managing the AMAG product submission and ensure compliance with local, state, federal and international laws, guidelines, and regulations.

 - Awareness and understanding of all applicable federal regulations relating to pharmaceutical products and implementation of all corporate regulatory policies and procedures.  Responsible for FDA regulatory contacts and submissions, including NDAs, INDs, supplements, Adverse Drug Responses (ADRs), IND maintenance, and periodic reporting.

Required Skills

 - Advanced Degree in scientific discipline with a minimum of 7-10 years  of Regulatory experience including 3 years of management experience

- Expert knowledge of regulations, industry practices and procedures

- Experience in domestic as well as international regulations 

- Ability to provide guidance across the company

This position is responsible for evaluating complaint investigation data to understand product performance and patient impact, draw conclusions related to safety and potential actions required, determine whether safety reports are required to be sent to global government agencies, create and file safety reports (MDR/Vigilance). Document all conclusions related to the complaint, ensuring the completeness and accuracy of complaint records.

• Evaluate information from internal and external sources
• Review complaint files to determine if they meet MDR/Vigilance reporting
• Prepare and submit both initial and follow up MDR and Vigilance reports as needed, ensuring all requirements are met
• Provide direction on whether manufacturing, product design, CAPA or clinical follow up is needed
• Review complaint files for closure
• Provide training on complaint process and reporting requirements as needed
• Perform trend analysis of complaint data and participate in corrective action process
• Produce clear, compelling and accurate reports
• Support requests for complaint information from customers

Requirements

• Bachelor's in Biomedical Engineering, Pre-Med or similar field
• 5-7 years experience handling MDR or MDV's
• Medical knowledge and understanding
• Ability to interpret regulations
• Medical device complaint handling
• MDR/Vigilance Reporting experience
• Analytical approach to problem solving
• Able to write clearly and succinctly
• Good communication skills
• Able to review data and quickly identify gaps
• Attention to detail

Candidate will perform chromatography immunoassay and other analytical method development in support of vaccine process and product development programs.

Requirements:

• Experience with protein characterization techniques and associated instrumentation such as HPLC/UPLC (RPC, SEC, IEX), Mass Spectrometry, Capillary Electrophoresis, etc.
• Hands-on experience with bioanalytical assay development and qualification of large molecule, such as ELISA, Western Blot
• MS/PhD  2+ years relevant experience

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.
www.cwsciences.com

Warp Drive Bio is seeking an experienced and highly motivated Mass Spectrometry/Biochemistry Research Associate to work as part of a multi-disciplinary team whose focus is the discovery and characterization of novel natural products from the genomic level through target identification to therapeutic applications. The successful candidate will use mass spectrometry to identify unique protein-compound interactions and support therapeutic target discovery and validation. Experience with LC-MS/MS applications, data analysis, and a firm knowledge of mass spectrometry fundamentals is required for this role. The candidate will also be expected to be able to assist the biochemistry group with protein expression and purification.

Responsibilities:

• Generation and analysis of proteomic samples from biological sources.
• Protein expression, optimization, and purification.
• Generation of vectors containing protein constructs for both bacterial and mammalian expression.
• Assist in development and evaluation of novel mass spectrometry and biochemical assays. 

Qualifications:

• BS or MS in Biochemistry or a related field with 2-4 years industry/academic experience with proteomics and/or biochemistry.
• Knowledge of and hands-on experience with LC-MS/MS analysis of peptides. S/he should be able to work independently when generating samples and also be able to interpret resulting data.
• 2-4 years of experience required in biochemistry and molecular biology including cloning, protein expression/purification from E. coli (knowledge of additional systems is a plus), immunoprecipitation and sample preparation for mass spectrometry analysis. 
• Practical experience with HPLC separations, proteomic sample preparation, and analytical software for protein identification and validation are desirable. Experience with quantitative proteomics approaches (e.g. iTRAQ, TMT, SILAC) is a plus.
• Independent individual with excellent communication skills who thrives in a fast-paced, interdisciplinary environment and has great attention to detail.

To be considered for this role, please submit your resume to careers@warpdrivebio.com

Warp Drive Bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. Warp Drive Bio is not responsible for any fees related to resumes that are unsolicited.

Primary Duties:
The Network Engineer is responsible for effective design, capacity planning, provisioning, and installation/configuration, documentation of LAN/MAN/WAN network hardware and software and related infrastructure (DNS/DHCP/WAN accelerator/etc.). The network engineer will continually evaluate business needs and assess new technologies to optimize network to meet Shire's business needs. The individual participates in technical research and development to enable continuing innovation within the infrastructure. This individual ensures that the network hardware, operating systems, software systems, and related procedures adhere to organizational processes and standards. This individual will assist project teams with technical issues, including the definition of needs, benefits, and technical strategy; research & development within the project life-cycle; technical analysis and design; and support of operations staff in executing, testing and rolling-out the solutions. Participation on projects is focused on smoothing the transition of projects from development staff to production staff by performing operations activities within the project life-cycle.

Responsibilities:
* 35% Engineering of network-related solutions for project and operational needs. Develop network design, oversee the installation of new / repurposed network equipment, configuration of network equipment, testing. Ensure design and configuration is consistent with standards and project/operational requirements. Document network for architecture, design and operational purposes. Engineering scope includes switches, routers, WAN packet shapers/accelerators, proxy servers, DMZ and WAN equipment
* 35% Develop and maintain installation and configuration procedures. Contribute to and maintain network standards. Strong focus on network and systems security. Provide ongoing Level 3 operational support to assist in the diagnosis and resolution of network problems. Support includes participating on operation calls, monitoring, assessing and isolating issues and anomalies and working with operations in resolving problems.
* 10% Research and recommend innovative and where possible automated approaches for network administrative tasks. Identify approaches that leverage our resources and provide economies of scale.
* 10% Perform ongoing performance tuning, hardware upgrades, and resource optimization as required. Periodically assess capacity demand and make a determination of changes required to optimize network to meet demand.
* 10% Consult with application or infrastructure development project to harmonize networks or infrastructure with standards and identify when it is necessary to modify the solution architecture to accommodate project needs.

Education and Experience Requirements:
• Bachelor's Degree in Computer Science or Information Technology strongly preferred
• Certification: CCNA, CCNP, or CCIE
• At least 5-7 years of relevant experience in working with clients (both at the management level and end-user level), consultants and multiple technology teams is essential.
• Experience in Life Sciences industry preferred but not required

Key Skills, Abilities, and Competencies:
• This position requires someone who is self-managing, able to work independently and capable of completing assignments successfully with minimal supervision.
• Networking: Switches, Routers, Servers, Cables, Racks, Firewalls, LAN, WAN, TCP/IP, DNS, UDP, VOIP, QOS EIGRP, BGP, OSPF, MPLS
• Must be inquisitive, confident and energetic
• Must be able to encounter unfamiliar technologies, application and situations, figure them out, and provide solutions that match both our clients' and our company's needs.
• Must very organized, dependable and detailed-oriented
• Must be able to meet deadlines in a fast-paced, agile environment
• Must have excellent verbal and written communication skills

Complexity and Problem Solving:
• Track record for remaining unbiased toward any specific technology or vendor, and for being more interested in results than preferences.
• Interpret and/or discuss information with others, which involves terminology or concepts not familiar to many people; regularly provide advice and recommend actions involving rather complex issues. May resolve problems with established practices.
• Position deals with a variety of problems and sometime have to decide which answer is best.

Internal and External Contacts:
Significant internal and external contact with IT peers and IT suppliers at multiple organizational levels.

Other Job Requirements:
* Moderate domestic travel is expected and will be agreed in advance wherever possible.
* Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives

Shire is an Equal Opportunity and Affirmative Action Employer

To apply for this position, pleaseCLICK HERE

Primary Role:
This position will participate in and/or be responsible for equipment, utilities, facilities, process and cleaning validation activities and projects for Shire HGT. Technical duties include authoring and executing validation documents, defining validation strategy, adhering to domestic and international GMP regulations, reviewing and analyzing data, incorporating continuous improvements into validation activities and policies, and participate in regulatory inspections as required. Leadership duties include incorporating industry best practices, acting as a change agent, and motivating others. The scope of responsibility encompasses drug substance manufacturing operations and the systems that both directly and indirectly support it. Routine travel between local Shire HGT operational sites is also expected.

Responsibilities:
Varies, 30-85% Write, execute, summarize, and lead validation activities in the following areas:
• Facilities
• Equipment
• Shipping / Cold Chain
• Process
• Cleaning
• Steaming / Autoclave
• Computer Systems
• Plant Automation
• Validation Maintenance
• Validation document control and archival program

Develop and assess the following Quality System elements for Validation:
• Quality Risk Management program
• CAPAs
• Change Controls
• Deviations
• GMP Investigations Lead and manage complex validation and technical projects.

On-going Identify opportunities for continuous improvements, deploy best practices, pro-actively update validation programs to reflect current regulations and trends. Varies, 5 - 15% Support compliance audits and/or inspection readiness activities. Author and review responses to inspection observations and agency questions. Support continuous improvement activities related to validation, quality, and compliance.

Education and Experience Requirements:
• Minimum requirements include a Bachelor's degree in a technical discipline, preferably engineering or biological sciences and a minimum of 5 years pharmaceutical and/or biopharmaceutical industry experience.
• An advanced degree or additional industry certification is a plus. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

Shire is an Equal Opportunity and Affirmative Action Employer

To apply for this position, pleaseCLICK HERE

Role Description:
This is a rare opportunity to shape the HR function in a successful multinational company as it transitions to a stand-alone environment.
The HR Lead LLN (GMS) will be responsible for all elements of local HRM, from strategy to service delivery for an organization of approx +200 colleagues in Louvain-La-Neuve.
Working in close collaboration with regional and global HR Leaders, and as a full member of the Site Leadership Team, the HR Lead GMS LLN will drive and implement global HR programs and processes ensuring alignment with business objectives.

Responsibilities:
HR Strategy:
• Implement key human capital strategies aligned with business objectives
• Partner with managers to initiate and implement optimal organization structure and drive culture and engagement.
• Leverage corporate change solutions to ensure an appropriate level of consistency across the company
• Ensure diversity & inclusion initiatives are integrated into all HR activities & policies
• Promote Zoetis’ culture and values
• Execute specific HR activities associated with mergers, acquisitions and divestitures
• Ensure compliance with corporate HR policies and local laws

Talent Acquisition:
• Partner with corporate Talent Acquisition as appropriate to
o Manage recruitment process in partnership with line leader and recruiting partners (if appropriate), to include job posting, candidate sourcing, interviewing, offer development, pre-employment screening, and applicant tracking
o Manage talent acquisition process to attract and retain exceptional talent
o Select and manage local vendor relationships and costs as appropriate

Talent Management:
• Administer corporate talent tools & programs to ensure appropriate talent pipeline
• Partner with business managers to
o Leverage corporate talent management and development programs to build colleagues' skills and competencies in alignment with business strategies
o Execute sub-region/country/function-specific human capital development activities
oAct as coach and business partner to leaders and business teams
o Manage Global Performance Management, midyear reviews, peer reviews and individual development plan processes

L&D
• Leverage the corporate L & D program to drive the regional strategy
• Ensure effective implementation of on-boarding program

Compensation & Benefits:
• Partner with corporate Total Rewards and HR Operations teams as appropriate to
o Administer annual compensation and rewards program, including calibration process and all year-end compensation activities
o Administer local salary/compensation structure, plan and delivery strategy
o Deliver and support local employee benefits programs (with outsourced vendor)
o Ensure regulatory and legal compliance of all benefit plans
o Consult with leaders on compensation decisions
o Partner with regional HR Operations to manage local vendor relations for benefits, managing service levels, coordinating operations, resolving issues
o Support local and international relocation process in partnership with outsource vendors and regional HR Operations

Labour & Employee Relations:
• Working in close alignment with the Site Leader, manage relationships with unions, works councils, employee forums as applicable
• Manage local employee communications
• Manage employee relations, grievances
• Ensure compliance with local labor laws and regulations
• Represent Zoetis in the community and with local agencies as appropriate

HR Operations:
• Partner with corporate and regional HR Operations units as appropriate to
o Ensure consistency, standardization & optimization of HR processes and technology delivery of HR services
o Manage employee data and record keeping; oversee time and attendance process; manage compensation administration
o Interface with payroll vendor as necessary
o Respond to employee inquiries

HR Alignment:
• Active member of the EUAFME regional HR leadership team
• Executes alliances with the Centers of Excellence (COE) and Enterprise organizations to ensure alignment of HR processes/programs in regions

Qualifications:
Education:
• Tertiary prof qual in HRM or related discipline required
• Master, MBA or related professional post graduate degree preferred

Experience:
• 5-7 years with demonstrated experience as an HR Business Manager
• Current know of employment law and experience of consultation processes
• Experience in HR function of global / international companies, comprehensive knowledge of one or more HR discipline and advanced knowledge of others
• Knowledge & experience of pharmaceutical and/or Animal health industry preferred

Skills:
• Excellent interpersonal/influencing skills, including the ability to effectively coach leaders, build relationships and leverage resources within the function and across the organization to advance business strategy
• Excellent written & oral communication skills in French and English
• Ability to work effectively in an environment of change and ambiguity
• Demonstrates excellent skills in leadership, integration, facilitation, complex problem solving, negotiation and conflict resolution
• Has strong business acumen and functional knowledge
• Strong numeracy skills
• Strong systems & process orientation
• Ability to exercise own judgment and be a resource for others.
• Ability to work independently with assignments often self-initiated
• Demonstrates initiative and willingly assumes additional responsibilities as necessary.

To apply for this position, pleaseCLICK HERE

Position Description:

We have an immediate opening for a Scientist / Sr. Scientist in biochemical assay development and optimization. 

The Scientist / Sr. Scientist will participate in interaction with QA/QC and Manufacturing to generate relevant SOPs, DHRs and other control documents as projects are transferred to Manufacturing. The Scientist / Sr. Scientist will also participate in design of QC assays and generate appropriate QA documents for product manufacture, playing a significant role in the Design Control process throughout product development, presenting at Design Control meetings, generating Design Inputs, Design Outputs, Risk Analysis documents and Failure Modes Analysis documents.  The Scientist / Sr. Scientist will assist in clinical trial protocol development and assist senior management with FDA regulatory compliance issues. 

Position Requirements:

Requires PhD in biology or chemistry with 2-4 years industrial experience with in vitro Diagnostic Assay Development.  Knowledge of GLP, GMP and QA/QC protocols and regulatory compliance is required.  Strong background in biology and biochemistry is essential.  Research backgrounds with blood proteins and/or in bacteriology are strongly preferred.   Hands-on experience with automated liquid handling instrumentation highly desired.