Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees.

With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.

Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Position Summary
Work as a liaison with the business and technical teams to recommend solutions to meet current and future business needs. Provide customer support for technical and process related requests for new or changed PDMS products and services.

Core Responsibilities
- Administration of PDMS applications
- Perform implementation and deployment activities such as data collection, loading, and verification.
- Address complex Helpdesk Tickets; requires interacting and troubleshooting with end users to identify issues and provide resolutions.
- Participate in the change management process for multiple applications.
- Provide instruction/guidance to system users on system functionality for multiple applications.
- Generate and maintain metrics for change management and customer support processes.
- Support end user software installation.

Additional Responsibilities
- Perform evaluation and continuous process improvement activities.
- Provide guidance to end users for development of cGxP compliant site procedures.
- Support report verification activities
- Collaborate with training team to develop and update training material content in accordance with system changes.

Qualifications
Basic Qualifications
- Bachelor's degree and 5 - 8 years.
- Master's degree and 3-6 years.
- 3 - 5 years documenting and supporting electronic systems or equivalent experience.
- 1 - 3 years of experience in a regulated industry

Must be able to:
- Successfully engage in multiple initiatives simultaneously
- Work independently with users to define concepts and under direction of project managers
- Drive and challenge business units on their assumptions of how they will successfully execute their plans
- Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of executives, managers, and subject matter experts.
- Strong analytical and product management skills required, including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.

Preffered Qualifications
- Software system administration experience
- Crystal Report design
- Knowledge of and experience with cGxP

To apply for this position, please CLICK HERE

OPK BIOTECH  LLC

QC Analyst I, Microbiology

OPK Biotech develops, manufactures and markets oxygen therapeutics, a new class of intravenously administered pharmaceuticals that increase oxygen transport to the body’s tissues.  OPK Biotech is headquartered and operates cGMP manufacturing facilities in Cambridge, Massachusetts and Souderton, Pennsylvania.

The QC Analyst I, Microbiology, will be responsible for environmental monitoring, water and steam testing in a quality control environment.  Testing responsibilities may include collection and testing of water and steam, environmental monitoring, data entry and filing.  Will included routine and non-routine microbial analyses on raw materials, in-process samples and finished product using common laboratory instrumentation. 

Responsibilities Include:

 Environmental  monitoring for controlled areas and during aseptic fills.

• Collect USP/EP purified, WFI water and clean steam as required and test according to Standard Operation Procedure for TOC, Bioburden and Endotoxin as needed.
• Conduct tasks associated with preparatory testing for Microbial Identification such as gram staining, etc.
• Receive and Inspect incoming supplies, media and reagents as needed.
• Utility sampling as required, (Nitrogen, Compressed Air, EM)
• Conduct Quality Control testing for Raw Materials, Media and other lab supplies
• Maintain labs, including maintenance of equipment, inventory of lab supplies as well as general lab organization.
• Work on special projects as assigned.
• Work in accordance with all internal, external regulatory bodies including GMP, ICH, and OPK Biotech SOP’s.
• Maintain Water and EM databases and filing of paperwork.
• Work overtime when needed.
• Other duties and responsibilities as assigned.

Job Requirements:

• Associate degree or higher in a scientific field of study preferable but not required.
• 2-3 years experience in a pharmaceutical microbiology laboratory setting would be a plus.
• Ability to perform aseptic gowning.
• Strong attention to detail a must.
• Excellent communications skills, both oral and written.
• Must be proficient with computers (Microsoft Word, Excel, and Access).
• Must be able to lift 25 pounds and climb ladders.
• Willing to work off shift, if required.

Please fax, email or mail to:

Human Resources, OPK Biotech LLC

 11   Hurley St., Cambridge, MA  02141  

Fax: 617-234-6507                email: hr@opkbiotech.com  

OPK Biotech is an equal opportunity employer.

ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Job Summary:

The successful candidate will develop and support a culture of health and safety excellence, and initiate and drive continuous improvements in health, safety and environmental training initiatives, systems and processes at ARIAD.  Because of ARIAD’s commitment to Environmental Health and Safety (EH&S) this position reports directly to the Senior Director of Global Real Estate and Facilities with an indirect reporting relationship to the Chair of the Institutional Safety Committee, currently the President of R&D.

Key responsibilities:

Apply professional knowledge and expertise in Occupational and Environmental Health and Safety, including work in the areas of chemical safety, biosafety and hazardous waste management, as well as other EH&S programs

Ensure that decision-making is based on established procedures; relevant laws; regulations and company policy; professional best practices; relevant scientific methodology; impact on other EH&S programs, and senior management approvals as required.

• Develop and implement awareness programs and targeted training to meet the needs and interests of ARIAD research departments, to support ARIAD's commitment to  safety, and to work with researchers and EH&S colleagues to ensure mechanisms are in place to monitor effectiveness.
  
  
• Develop and maintain the framework of guidelines and standards, to ensure a business oriented, efficient and effective, integration of health and safety practices in Cambridge, and other ARIAD sites.
  
  
• Analyze and implement changes and new regulatory or guidance documents from local, state and federal agencies (e.g. NIH, CDC, OSHA, FDA, EPA, MADEP). Communicate with agencies (regarding regulatory or guidance document interpretation and implementation related to ARIAD oversight

• Work with the Institutional Safety Committee to set the directions of corrective actions and improvement programs. In addition, serves to bring together common practices across all laboratories.

• Ensure activities related to the use of hazardous materials (biological, chemical, radiological, etc.) in laboratories are conducted in a consistent and safe manner, in  strict compliance with federal, state and local  regulations

• Partner with research managers in the performance of workplace hazard assessments.

• Work with associates to implement policies and procedures for Biosafety, Chemical Safety, Radiation Safety, Emergency Preparedness, and the procurement, use and disposal of hazardous materials.

• Respond to laboratory emergencies

• Manage EH&S permitting and licensing in compliance with Federal, State, and Local regulations.

• Conduct inspections to confirm that EH&S program components are being observed by staff.

•  Develop & deliver training for all safety programs required for compliance with federal regulations, e.g., Emergency Preparedness, Hazard Communication, Chemical Hygiene, Biosafety, Bloodborne Pathogens, Radiation Safety hazardous waste management, etc..

• Participate in review and analysis of exposure and incident reports, including medical surveillance involvement

• Perform ergonomic evaluations

• Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.

• Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Basic Qualifications:

• Bachelor's degree in biological, chemical or engineering sciences
• Master’s degree in Industrial Hygiene a plus;
• Certification as an Industrial Hygienist (CIH) or certification as a Safety Professional (CSP) is preferred.
• Knowledge of: OSHA, DEP, EPA, RCRA, DOT, DPH, MWRA, NIH, NFPA, DEA, CDC regulations as they pertain to pharmaceutical/biotechnology research
• Thorough knowledge/understanding of hazardous materials, chemical and biological principles and hazards relating to laboratory safety, general knowledge/understanding of basic EH&S and/or industrial hygiene principles, including related laws and regulations.
• Hazardous waste management experience a plus
• Thorough written, verbal, and interpersonal communication skills, including political acumen and skill to communicate effectively in a diverse environment.
• Strong analytical and organizational skills to organize prioritize and manage the successful completion of projects within time and budget constraints.
• 5+ years experience in a research laboratory setting (biotechnology, pharmaceutical research, academic science or EH&S) related work experience
• Experience working in an biotech/pharmaceutical company a plus
• Experience with providing training and using Personal Protective Equipment.
• Experience with Sharepoint, Microsoft Outlook, Word, and Excel
• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

Submitting a resume online at a job site could cause valuable screening information to be missed.

Click here to apply:
http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=240&company_id=16419&version=1&jobboardid=306

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Job Summary:

Reporting to the Senior Director of Global Real Estate and Facilities (GRE&F), the successful candidate will administers the standards and workflows for the GRE&F document management system, and enhance the efficiency, quality control, access and revision management of GRE&F documents.

Key responsibilities:

• Administer and maintain the standards and workflows for GRE&F document management.
• Administer and maintain the collection, publication, storage and retrieval of GRE&F,( including real estate, facilities, engineering, construction, operations and Environmental Health and Safety) documents such as drawings, contracts, agreements, leases specifications, manuals, procedures, records.
• Administer and maintain the document lifecycle (author, approve, publish, revise, retire, archive) of GR&F documents, including training records, agreements, plans, specifications, manuals, procedures, policies, guidelines and standards, etc
• Prepares electronic document templates.
• Updates procedures as required.
• Maintains the master electronic project files in sharepoint and department drives.
• Prepares records for inactive storage according to the Records Retention Schedule.
• Manages document processes and systems to ensure control and availability of documentation Reviews new and revised documentation for suitability and conformance to ARIAD standards including record retention.
• Works as a facility team member to provide documentation support to the facility and project team.
• Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
• Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.
• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.
• Assists in providing training on documentation 
• Responsible for identifying and implementing efficiency improvements to the overall document control process.
• Draft documents as requested
• Keep records of department meetings
• Other tasks as assigned

Basic Qualifications:

• Bachelor’s Degree, or equivalent work experience in a facilities role
• At least 5 years of experience in document control/document management or similar work
• Experience working in an biotech/pharmaceutical company preferred
• Experience with Sharepoint, Microsoft Outlook, Word, and Excel

Submitting a resume online at a job site could cause valuable screening information to be missed.

Click here to apply:
http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=241&company_id=16419&version=1&jobboardid=306

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

The Quality Control Manager will manage the quality control function to drive quality improvements and continuous improvement efforts associated with the quality of products and the processes and testing of analyzers and reagents. 

Responsibilities

• Drive the current quality control practices of testing, data collection and reporting, ensuring compliance to FDA and ISO requirements 
• Analyze and act upon quality reports and quality database, collect, summarize, and post data on quality metric performance
• Support engineering and manufacturing quality improvements with procedures, processes and quality engineering tools with data and statistics to gauge effectiveness of improvements
• Ensure compliance to customer requirements

Requirements

• BS degree in a technical discipline, preferably life sciences or medical technology with 8+ years of Medical Device/IVD experience
• Prior experience supervisory experience in an FDA regulated reagents, medical device or IVD manufacturing company
• Strong working knowledge of ISO 13485, IS9001 and FDA Regulations (21 CFR Part820) 
• A thorough understanding of quality improvement tools, i.e. Six Sigma and Lean Manufacturing along with a strong knowledge of statistical methods including statistical process control and sampling techniques
• A demonstrated failure analysis experience working with cross-functional groups to determine root cause, excellent communication skills and the ability to work well under pressure with cross functional teams
• Strong MS Office skills  ASQ Certified Quality Manager, quality engineering, Six Sigma Certification is/are a plus 

Please submit resume to: careers@biomedicalsearch.com with QC Manager in the subject line

The Compliance Auditor IV will be responsible for the coordination and preparation of internal and external audits and compliance in accordance with international GMP/GDP requirements and Alexion Quality standards. External audits include raw material and component suppliers, contract manufacturer’s (API and fill finish facilities), contract laboratories, labelers and packagers, warehouses and distributors, some of which are located in other regions. This position collaborates with Alexion GMP areas, suppliers, and contract manufacturers to develop positive and proactive approaches to regulatory compliance; participates in good laboratory practices; training of functional areas and assists in the development of training sessions.  The Compliance Auditor IV will be responsible for interpreting GMP regulations to perform GMP audits according to an approved global audit schedule. The incumbent will ensure timely issuance of reports, review of responses, follow-up on corrective actions and audit closure. A key responsibility will be to work closely with the QC organization to conduct audits to support the Vendor Qualification Program and with the QA organizations to conduct pre-assessment visits of potential third party business partners.  Travel approximately 30-40% of the time with the majority of travel domestic in scope.

Principal Responsibilities

• Assembles audit teams with appropriate skills and experience and ensures audits of internal departments and external sites are performed according to approved global audit schedule;
• Partners with QC, or other department, subject matter experts to conduct assessments and/or audits to support Vendor Qualification Program and contractor audits;
• Leads or participates in internal audits of Alexion Rhode Island Manufacturing site and other Alexion sites to assess compliance to international GMP requirements and Alexion Quality standards. May conduct audits to assess inspection readiness of Alexion and contractor sites;
• Leads the preparation for and conducts audits of raw material, component suppliers and service providers for the Alexion Rhode Island Manufacturing site. May lead or participate in audits of contract manufacturers, labelers/packagers, contract laboratories and distributors to evaluate processes, systems and procedures for compliance to cGMP requirements and Alexion Quality standards. Assigns responsibilities to audit team members and provides audit preparation materials, instructions and training as appropriate;
• Ensures timely issuance of audit reports and follow-up on responses and corrective actions. Tracks completion of activities from scheduling through audit closure;
• May perform for cause audits of business partners to assess regulatory risk and propose recommendations to senior management;
• Partners with local QA teams to coach and train staff on regulatory requirements, provide visibility to current agency trends and maintain compliance of Alexion sites;
• Maintains in-depth knowledge and understanding of current regulations and guidelines that apply to the types of facilities and functions being audited as well as applicable jurisdictions; 
• Interacts effectively with management of 3rd parties as well as management and peers of internal departments. Utilizes a collaborative approach to auditing and provides recommendations to auditees to maintain GMP compliance;
• Assists and advises the Manager, QA Compliance, as required.  Provides recommendations and input regarding compliance of internal department systems, procedures, investigations, etc.  Fulfills appropriate responsibilities and making judgments and decisions in a sound logical manner;
• May create or revise standard operating procedures relating to inspection readiness, internal audit program, supplier monitoring, supplier audit program, and other related documentation;
• May coordinate activities and assists with interactions during regulatory agency inspections; 
• May direct interaction with regulatory agencies on defined matters; 
• Assists with the corrective action implementation;
• Performs other duties as required.

Qualifications

Work Experience

• 8 - 12 years demonstrated practical experience in auditing GMP facilities for the biotech/pharm. industry or related experience; and sterile GMP facilities is required;
• Thorough knowledge of cGMP/GDP and international regulatory requirements is essential;

Education

B.S. degree in Chemistry, Biology or related field

Major Skills  

• Works on complex problems in which analysis of situations or data requires an evaluation of intangible variables;
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results; 
• Acts independently to determine methods and procedures on new assignments and may provide guidance and oversee audit preparation or remediation activities;
• Candidates must possess effective interpersonal, written and verbal communications skills, along with a team-oriented approach to project management and problem resolution.
• Ability to travel both domestically and internationally

Experience & Know-How

Specialist Jobs: A trusted professional who can act independently in their role.

Problem Solving & Complexity

Specialist Jobs: Job works on problems of diverse scope in which analysis of situation or data is required. Exhibit a great degree of inginuity, creativity and ressourcefulness.

Decision Making & Accountability:

Specialist Jobs: Works independently. Exercises judgement within generally defined practices and policies.

Management Responsibility

Individual contributor with no people management responsibilities

Job Title

Sr. Manager, Manufacturing – Purification

Job Title (Local) : 

Sr. Manager, Manufacturing – Purification

Function: Manufacturing 

Location: Smithfield, RI

Reports to: Associate Director, Purification & Central Services                

Purpose of the Job

The Senior Manager has responsibility for purification operations in a 24/7 manufacturing facility for commercial manufacturing of biopharmaceuticals.  The Senior Manager will provide leadership to the purification team by building a strategic vision for personnel development, process improvement and systems.   This position will serve as a subject matter expert during regulatory inspections and be accountable for maintaining an inspection-ready operation at all times.  Additionally, the position will be responsible for driving continuous improvement efforts and cross-functional collaboration with other departments within Alexion Pharmaceuticals, Inc. to support company goals and site metrics.

 Principal Accountabilities

Develop, implement and monitor departmental objectives and schedules including setting priorities and performance expectations while ensuring alignment with expected deliverables, site metrics, and company goals

Manage and develop a staff of 10 full time manufacturing associates and 2 supervisors

Manage staff to project timelines effectively while ensuring clear and concise communication to plant management

Effectively manage data entry into the enterprise resource planning database to maintain a compliant trace of all raw materials, solutions and consumable items used in the manufacturing process

As appropriate, coordinate and lead deviation, change control and process improvements for area of responsibility, identify root causes and implement appropriate corrective and preventive actions to prevent repeated occurrences

Serve as subject matter expert during regulatory inspections, and collaborate with plant management to address any follow-up responses or corrective actions

Ensure effective interactions with other departments and customer representatives as appropriate to support site metrics

Effectively recruit and develop staff in accordance with company policies in support of effective succession planning

Develop and manage portions of the departmental budget and spending in support of department objectives for cost control while maintaining effectiveness

Major Skills

Job-related Skills / Technical Know-How

Level

Strong working knowledge of cGMP manufacturing operations and ability to maintain regulatory requirements for compliance at all times

Proficient

Comprehensive understanding of logistics constraints of operating large scale equipment in a commercial manufacturing plant, under a rigorous production schedule

Proficient

Must have excellent written, verbal, and presentation skills with a demonstrated ability to work effectively in a fast-paced team environment

Proficient

Strong technical knowledge of purification theory with a demonstrated ability to effectively implement continuous improvement initiatives that will contribute to process robustness

Proficient

Must be able to communicate clearly, effectively, and concisely with subordinates, peers and management

Computer Literacy Level

Must have good working knowledge of MS Excel, Word, Powerpoint, and Project

Job-related

People Management

Demonstrated ability to lead a team of manufacturing staff through successful cGMP inspections by internal auditors and external agencies,while ensuring a high degree of compliance

Demonstrated ability to organize and lead manufacturing operations on a campaign and continuous basis, to develop leaders in the organization, and to provide opportunities for staff to grow

Ability to inspire, organize and lead continuous improvement efforts within purification manufacturing operations and participate in site-wide continuous improvement efforts

Demonstrated ability to promote a positive work environment by effectively administering company policies and procedures, maintaining a satisfactory safety record for the department, and monitoring performance management in line with HR policy.

Skills

Education:

BA/BS in Biology, Chemistry, Chemical Engineering or related discipline

Work Experience:

8+ years commercial biopharmaceutical cGMP management, significant experience within a large scale mammalian cell culture biopharmaceutical manufacturing facility

Internal and External Relationships

Quality Assurance, Technical Manufacturing Services, Logistics, Quality Control, Validation, Automation, Human Resources, Metrology, Vendor Representatives, Contractors

Manager Regulatory Operations

Verastem is looking for a highly motivated candidate interested with a challenging career opportunity within a top-tier biotechnology firm. We provide a highly stimulating work environment coupled with a high level of professional and intellectual challenge.

This position reports to the Vice President of Development.

• Plans and prepares regulatory documentation, including eCTD production needed for existing and new INDs, IND amendments, annual reports, CTAs, IMPDs, NDAs, MAAs, orphan designations, meeting requests, protocol assistance, etc.,
• Submits regulatory documentation according to established timeframes
• Keeps current with and informs others in the group of new FDA, EMEA and ICH guidance documents
• Works with Vice President of Development  and external regulatory consultants to implement regulatory strategy to advance Verastem products to approval as quickly as possible while remaining in compliance with all applicable regulations and guidelines
• Helps maintain regulatory files
• Other duties, as required

Education and Experience

• BS in a biological or pharmaceutical science
• Three to five years direct regulatory experience in a biotech or pharmaceutical company
• Knowledge of US, EU and Canadian drug regulations
• Excellent written and oral communications skills
• A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
• Good interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective      interactions within and across departments

Job Title  : 

QC Compliance Specialist IV

Department: Microbiology

QC Microbiology Job Summary

This position will serve as a point of contact for all Quality Control Department Change Controls, Deviations, Investigations, and CAPAs.  This individual will work closely with various QC Micro personnel to assist in the preparation of clearly written documents for review, and represent QC during collaborations with QA and other department representatives to obtain understanding and approval for these QC generated records. 

The individual in this position will facilitate and/or perform data verification and data audits for QC support activities related to release data, stability, technical reports, CMC and APR sections, and quarterly QC metrics. 

 Principal Responsibilities

1. Write and/ or review QC deviation, investigation and CAPA records.
2. Represent QC Micro at cross-functional meetings and report to QC management on items / topics impacting QC Micro and QC in general.
3. Facilitate and track the approval and implementation process for all QC Change Controls and assigned tasks through approval
4. Work closely with QA counterparts representing QC Micro on all quality system and compliance issues, including but not limited to Change Control, deviations, investigations, training and CAPAs
5. Design and maintain tracking tools to monitor QC Micro commitments and assignments related to compliance and quality systems including internal and external audit observations/recommendations.
6. Perform data audits of QC laboratory data submitted for product release and stability testing.
7. Serve as a point – of – contact with CMC staff for all QC Micro assigned requests  for the preparation, review, and/or verification of CMC sections for Regulatory filings and of responses to Regulatory questions; manage the assignment of specific requests to various QC Micro staff against timelines and track progress through completion.
8. Perform review and audit of QC Micro procedures for consistency and compliance; make recommendations to QC Micro managers for harmonization and improvement of procedures and practices to maintain compliance 
9. Audit data packs and prepare certificates of analysis for drug substance and drug product as required to meet Supply Chain and Regulatory CMC requirements; maintain lot specific tracking tools for all certificates
10. Prepare certificates of analysis for Alexion reference standards and cell banks

 Qualifications

Work Experience

-          The individual in this position is expected to have experience and an in depth understanding of QC Micro operations and Quality Systems for pharmaceutical manufacturing environment, including but not limited to, release and stability testing, OOS, deviations, CAPAs, root cause analysis, data integrity, training and good documentation practices

-          Experience with health authorities guidelines and regulations as they relate to Microbiology, cell banks, virus safety testing, and general industry best practices.

-          The individual in this position will be able to organize his/her own work on a routine basis and requires minimal supervision.  The individual must be able to provide updates and tracking on his/her tasks.

 Education

- BS degree, with 5-8 years of relevant GMP experience; experience with product specifications related to biologic drug products

 Major Skills

• Good communication skills required, both verbal and written.

  Experience & Know-How

Specialist Jobs: Position requires skills of a seasoned professional with in-depth specialization

Problem Solving & Complexity Choose from the menu below the level of complexity & problem solving that is normal for this job.

Specialist Jobs: Job works on problems of diverse scope in which analysis of situation or data is required. Exhibit a great degree of inginuity, creativity and ressourcefulness.

Decision Making & Accountability: 

 Specialist Jobs: Works independently. Exercises judgement within generally defined practices and policies.

 Management Responsibility Choose from the menu below the kinds and levels of personnel managed by this job

 Individual contributor with no people management responsibilities

Constellation Pharmaceuticals is committed to developing cutting edge therapies based on our understanding of how epigenetic mechanisms impact important cellular processes, including transcription, replication and DNA repair in the areas of oncology and inflammation.

We are seeking a highly motivated research associate with a background in protein purification and cell biology/molecular biology to work in the protein group in the biology department to support drug discovery efforts in a highly collaborative, goal-oriented and fast-moving environment. This position requires excellent time management skills and expertise in protein biochemistry methodologies.

Responsibilities:

Primary responsibility will be conducting protein purification and in vitro research to support early drug discovery programs.

Work responsibilities may include, but not limited to, cell biology, in vitro target validation, development of in vitro cell based assays, and analysis of data. Additional skills may include knowledge of Mass Spectrometry based technology for discovery and targeted quantitative proteomics studies. The candidate will be particularly focused on optimizing and implementing biological sample preparation, and executing SOPed proteomics experiments.

Position requires active interaction and collaboration with project team scientists. The responsibilities also include basic lab organization and maintenance, as well as excellent documentation skills.

Requirements:

• BS/MS      in biology or other relevant fields.
• A      minimum of 1 year of postgraduate laboratory experience (industry setting      preferred).
• Expertise      in protein purification and mammalian cell culture is highly preferred.
• Experience      with molecular biology techniques and cell-based assays will be highly      preferred.
• Strong      oral and written communication skills and an ability to successfully work      as part of an integrated, interdisciplinary team.

Constellation Pharmaceuticals is an Equal Opportunity Employer, 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

ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Summary

This is an exciting opportunity to join ARIAD Pharmaceuticals, a rapidly expanding company dedicated to discovering innovative cancer therapeutics that transform patients’ lives. The successful candidate will be a critical member of the Finance team.  Reporting to the VP of Finance, Controller the Purchasing Manager will work closely with department managers and employees and manage the procurement of a variety of materials, office/business supplies, scientific equipment and services and for the company. S/he will evaluate the existing supply base for cost, quality and performance, facilitate streamlined processes and be the primary liaison between the internal customer and the supplier.

Duties and Responsibilities 

Strong proficiency in Oracle ERP eBusiness suite.

Create and maintain mutually beneficial long-term partnerships with suppliers.

Work to reduce the internal Cost of Ordering by identifying non-value activities and eliminate wherever possible.

Ensure that competitive pricing is achieved by Quoting out all new Products, and re-quoting a sample population of existing items of our preferred suppliers on an annual basis.

Communicate frequently with internal customers and suppliers regarding, customer service, process improvements and cost saving ideas.

Maintain strong relationship with internal Customers and assist with all purchasing enquires. Respond immediately to requests. Anticipate and prepare for potential issues.

Demonstrate effective utilization of existing purchasing planning policies, procedures, systems, and documented processes, ability to maintain and update procedures

Recommend and drive improvements. Keep up to date on Best Practice purchasing skills. Systems skills include ERP/Oracle, in addition to Word and Excel.

Manage the day-to-day operation within the purchasing department.  Including supervision of the purchasing staff in the daily activities of placing and track orders, maintaining the supplier database, and other special projects.  Work closely with accounts payable and receiving to correct all issues and discrepancies.

Act as a purchasing resource for the Switzerland location.

Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.

Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization

• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

Requirements

Bachelors Degree in Finance, Business, Life Sciences or related discipline

Minimum 7-10 years of experience in purchasing/ procurement experience as Buyer or Purchasing Manager in the Biotech, Pharmaceutical, and or Medical Device

Demonstrated proficiency with Oracle IProcurment

Must possess proven ability to negotiate supplier pricing, demonstrated analytical and problem solving skills

Strong commitment to business ethics

Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

 Submitting a resume online at a job site could cause valuable screening information to be missed.

Click here to apply:

http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=242&company_id=16419&version=1&jobboardid=306

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

Database Strategy Senior Analyst role supports the DSRM (Drug Safety & Risk Management) business unit in the collection, management, storage, analysis and reporting of safety data in compliance with regulatory requirements. This role blends knowledge of Drug Safety operations and associated regulatory requirements with strong clinical and/or technical expertise to ensure the highest data quality possible and to meet the business unit’s reporting and analysis needs in support of managing the safety of BIIB’s marketed and investigative products.
At the Senior II level, this person is viewed as an expert within the Database Strategy group and provides leadership to the group and the DSRM department overall. This person works directly with the DSRM Sr. Managers to recommend policy and standards and develop new techniques and strategy for data handling, retrieval and reporting to support all aspects of the DSRM business activities. This person also acts as a mentor for the junior DSAs with some project management responsibilities. The DSA keeps up with trends in the industry and regulatory environment in order to assist the Database Strategy group in creating processes and tools to stay ahead of the competition.

Technical/Software skills:
• Knowledge office systems such as MS Word, MS Excel
• Knowledge of relational databases and database concepts
• Database design and data modeling techniques
• Familiarity with SQL
• Programming experience
• Working knowledge of AERS or similar drug safety reporting database
• Working knowledge of Business Objects or similar data query and reporting tool
• Working knowledge of Halo or similar safety signaling system
• Knowledge of data analysis and trending
• Familiarity with statistics

Experience:
• 4 to 6 years working in Drug Safety or Data Management in the biotechnology/pharmaceutical industry or similar experience working within a CRO or clinical environment

Non-technical skills:

Senior staff should have strategic vision in addition to operational excellence and demonstrate the following qualities; Analytical, Forward looking, Insightful, Intuitive

Qualifications:

• Solid leadership and communication skills
• Solid presentation skills with presentations to both large and small audiences.
• Solid project management skills including managing multiple projects across multiple functional areas.
• Excellent analytical and problem solving skills in a dynamic environment.
• Ability to align individuals with program goals and to build consensus.
• Ability to organize and manage multiple tasks in a fast-paced environment, within established budgets and timelines.
• Ability to work collaboratively in a dynamic, team-based environment.
• Ability to work independently on all assigned tasks and projects
• Ability to prioritize and adjust project plans appropriately
• Ability to anticipate issues and develop plans to minimize their impact
• Ability to communicate principles and practices of DSRM Database Strategy group while advancing the goals of a cross-functional team
• Willingness to travel (• Demonstrated ability to learn and embrace new technologies, applications and solutions
• Cool in crisis/Level-headed
• Tolerant, Flexible, Pragmatic
• Diplomatic and persuasive

Education:

Bachelor degree, advanced degree preferred, in biological sciences, medically related field or computer/database related field. Knowledge of US and international drug safety regulations.

https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=169&siteid=5140&AReq=17771BR&Codes=MBC

The Principal Business Process Analyst will work as a member of the corporate Supply Chain Systems and Tools group with a primary focus on analyzing business needs and processes, defining business requirements, writing functional specifications, developing test plans, and supporting production applications. The Principal Business Process Analyst will serve as an intermediary between the corporate supply chain group, Information Systems groups and vendor solution teams in delivery of technology supporting supply chain related systems across Genzyme business units.

The Principal Business Process Analyst will apply strong business domain knowledge, analytical problem solving, and systems and applications expertise in support of multiple business systems related to supply chain management.

Roles and Responsibilities:

• Develops thorough understanding of the business functions supported
• Evaluates business requirements, presents capabilities, and recommends business systems solutions based on technical and business suitability
• Develops and documents functional requirements, specifications, system test scripts and support activities
• Guides the successful completion of design efforts and functions in a project team leader role
• Utilizes leading practices during and after project implementation
• Provides strong business process focus in support of improvement efforts
• Works closely with developers and a variety of end users to ensure technical compatibility and user satisfaction
• Ensures consistency and compatibility across the multiple projects and systems where appropriate
• Maintains application configuration files and related documentation
• Performs system troubleshooting
• Resolves helpdesk tickets as assigned
• Provides end user training as needed
• Escalates support issues to information systems and vendor technical support teams
• Tests application updates and enhancements prior to production deployment
• Designs, tests, and supports end user reporting
• Works with governance teams to define, monitor, and maintain critical master data elements

Basic Qualifications:

• 10 years' experience of supply chain experience in a manufacturing environment

Successful Candidates Should Also Possess:

• 5+ years' experience in the design, development, analysis, modification, configuration, implementation, and/or support of ERP or other supply chain related information systems
• 5+ years of understanding of application, database and systems development lifecycle
• 5+ years exposure to master data management and data modeling/reporting concepts
• Demonstrated training or 3-5 years use of MS Office tools

Preferred Qualifications:

• Bachelor's degree in Computer Science, Information Technology, Business Administration or related field

About us...
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

To apply for this position, please CLICK HERE

The Principal Business Process Analyst will work as a member of the corporate Supply Chain Systems and Tools group with a primary focus on analyzing business needs and processes, defining business requirements, writing functional specifications, developing test plans, and supporting production applications.

The Principal Business Process Analyst will serve as an intermediary between the corporate supply chain group, Information Systems groups and vendor solution teams in delivery of technology supporting supply chain related systems across Genzyme business units.

The Principal Business Process Analyst will apply strong business domain knowledge, analytical problem solving, and systems and applications expertise in support of multiple business systems related to supply chain management.

Roles and Responsibilities:

• Develops thorough understanding of the business functions supported
• Evaluates business requirements, presents capabilities, and recommends business systems solutions based on technical and business suitability
• Develops and documents functional requirements, specifications, system test scripts and support activities
• Guides the successful completion of design efforts and functions in a project team leader role
• Utilizes leading practices during and after project implementation
• Provides strong business process focus in support of improvement efforts
• Works closely with developers and a variety of end users to ensure technical compatibility and user satisfaction
• Ensures consistency and compatibility across the multiple projects and systems where appropriate
• Maintains application configuration files and related documentation
• Performs system troubleshooting
• Resolves helpdesk tickets as assigned
• Provides end user training as needed
• Escalates support issues to information systems and vendor technical support teams
• Tests application updates and enhancements prior to production deployment
• Designs, tests, and supports end user reporting
• Works with governance teams to define, monitor, and maintain critical master data elements

Basic Qualifications:

• 10 years' experience of supply chain experience in a manufacturing environment

Successful Candidates Should Also Possess:

• 5+ years' experience in the design, development, analysis, modification, configuration, implementation, and/or support of ERP or other supply chain related information systems
• 5+ years of understanding of application, database and systems development lifecycle
• 5+ years exposure to master data management and data modeling/reporting concepts
• Demonstrated training or 3-5 years use of MS Office tools

Preferred Qualifications:

• Bachelor's degree in Computer Science, Information Technology, Business Administration or related field

About us...
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine.

As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

To apply for this position, please CLICK HERE

Working in Global Materials Corporate logistics and understanding and interpreting logistics processes following the flow of materials, the Cold Chain Logistics Engineer will be responsible for supporting the development of shipping systems used for Global distribution of Genzyme GMP products. The Cold Chain Logistics Engineer will be responsible for developing design specifications to meet GDP, and Global Regulatory requirements. As the Cold Chain Logistics Engineer, you'll partner with cross functional groups to ensure that logistics solutions are designed, developed and qualified and meet product requirements and be responsible for development of URSs, design and route qualification, development of technical justifications, and associated protocols and reports. You'll help investigate and analyze the impact of new shipping systems assessing technical performance, operational efficiencies, sustainability and time to implementation.

Responsibilities:

• Work together with Sr. Logistics Engineer and Distribution sites to introduce and implement robust shipping systems
• Work with cross functional teams to develop science based methodologies and Technical justifications
• Develop URSs, design and route qualification, ambient temperature profile analysis, development of and associated protocols and reports for design development and qualification phases
• Initiate, write, review or approve MSs
• Develop and communicate global Temperature Excursion metrics
• Manage Testing supplier activities and schedule;
• Understand Thermal Modeling presented by suppliers & be able to apply based on Risk
• Develop standard operating procedures and work instructions for D&L functions/ activities
• Assist w/Deviation, CAPAs and Change Control activities
• Understand, review and critique supplier documents.  Understand new technologies and impact
• Assist in the integration of all projects functional requirements into a complete project plan
• Define work-plans, timelines and deliverables and monitor project status including status reporting and manage issue resolution and escalation and ensure delivery of project targets for logistics improvement project
• Work with cross functional teams to develop statistically and scientifically sound methods supported by processes like FMAE for process improvement
• Prepare operational GOPs for Thermal Shipping Systems
• Develop and maintain databases for shipping system qualifications
• Perform Testing Activities (Thermal, physical etc.)

Basic Qualifications:

• BS in Chemical, Mechanical or Industrial Engineering
• Minimum of 5 years industry experience of demonstrated project management
• Minimum of 3 years' experience in Temperature Controlled Supply Chain Management; experience with computational heat transfer thermal modeling

Successful candidates must also possess:

• Knowledge of GDP and GMP requirements for storage and transport pharmaceutical products
• Experience in material handling, material warehousing and distribution
• Experience in project management and leading/supporting cross functional teams
• Possess and demonstrate working knowledge of the design and testing of active and passive shipping systems
• Business Communication: Writes, speaks, and presents clearly and succinctly across a variety of communication settings and adjusts communication style to the audience by translating and articulating technical concepts to non-technical groups
• Ability to prioritize and balance multiple priorities, including line management responsibilities with assigned project work
• High degree of professionalism and organizational astuteness
• Analytical and quantitative skills and must have a proven ability to translate data into decisions
• Cross-functional knowledge: Uses knowledge of functional areas, organizational structure, and key business drivers to support company initiatives and long-term growth strategies, understanding individual and functional impact on the whole organization
• Excellent communication skills both written and verbal. Prior Biopharmaceutical experience preferred
• Proactive, open minded and self-motivated
  

Preferred Qualifications:

• Demonstrated experience with temperature controlled managed products; knowledge of ISTA & ASTM testing programs.
• Ability to work independently and in a matrix environment
• Demonstrated experience and possessing knowledge of freight transportation carrier selection and transportation regulations (domestic and global) with experience in cold chain shipping, validated shipping containers/systems, and import / export processes / documentation

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine.

As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

To apply for this position, please CLICK HERE

This position will be responsible for providing a broad range of strategic and tactical HR support to organization. This will include providing expertise in talent acquisition and retention, employment practices, employee relations, organizational development and management coaching, performance and change management, regulatory compliance, and training.

Job Responsibilities

• Play a lead role in the Talent Acquisition efforts for Merrimack including developing and implementing long-term workforce plans and creative recruiting strategies to source high quality candidates. 
• Manage the Merrimack Interview and Selection process ensuring the process is effective in selecting the most qualified candidates with the highest likelihood of being successful in our work environment.
• Manage the Merrimack On-Boarding process ensuring it is a high quality program that positions new employees to be successful. 
• Partner with the organization in leading the talent management process, including annual talent and compensation reviews and organization planning to accelerate leadership development at all levels.
• Ensure that the appropriate systems and process are in place for HR operational activities (HR and benefits administration, employment and regulatory compliance, and client service).

 Requirements and Experience

• 8-10 years of related HR experience.
• Bachelor Degree in Business or related field; Master Degree a plus.
• Demonstrated ability to create and execute successful recruiting strategies.
• Strong analytical and problem solving skills, ability to analyze data, understand trends and develop recommendations for action based on the analysis.
• Proven ability to build effective relationships with key business leaders and employees at all levels.
• Proven experience coaching and counseling all levels of staff on a variety of issues.​

BioPharmaceutical Facilities Technician

 Our client, BioPharmaceuticals company has an immediate opening for a Facilities Technician.

Responsibilities:

Position performs a variety of general repairs, installations and maintenance on facility equipment, building and utility systems. Performs analysis of facility / equipment operations and/or processes for continuous improvement in quality, safety and/or efficiencies. Provide support by documentation of maintenance, training, and/or validations business needs.

Qualifications:

• 2 year advanced eduation in facilities maintenance related curriculum or equivalent experience.
• 4+ years experience as Facilities Technician preferably in the pharmaceutical manufacturing/packaging industry.
• Prefer specialized training / certification / license in one or more maintenance disciplines such as refrigeration, HVAC, plumbing / pipe fitting, mechanical repair, hydraulics, pneumatics, etc.
• Should have working knowledge of cGMPs.

Arsenal Medical is an early-stage, medical device company that is bringing biomaterials systems to the clinic to improve patient outcomes. We are a multi-disciplinary team of biologists, chemists, materials scientists, and engineers, working in close collaboration to understand the biology of disease and to create solutions that address some of today’s most challenging and critical unmet medical needs.  Arsenal Medical has created a state-of-the art research and development environment in the Boston metropolitan area.

We are looking for an experienced product development engineer to support the design and development of novel products.

Key areas of responsibility:

• Apply sound engineering principles and practices to the design, assembly, and testing of implantable, biomaterials-based medical devices and delivery systems
• Collaborate to define, document and drive the design of prototype devices for evaluation and testing of new design attributes and product concepts
• Define and execute milestones and timelines as part of project planning
• Participate in and document development activities through lab notebook, design history file, reports and other records in accordance with Design Control (examples include Risk Analysis, Product Specifications, Verifications, Validations) and company procedures
• Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the development and manufacture products, include support of applicable regulatory submission and Design History File documents
• Develop and implement design elements including assembly, packaging and sterilization
• Contribute to and participate in design reviews and project reviews

• Develop new test methods, complete measure system analysis, support the creation of design specifications,
• Identify and establish working relationships with outside materials suppliers, OEM equipment designers, and contract manufacturers to develop designs, tooling, fixtures, test methods, and inspection methods

Qualifications

• B.S. or M.S. in Mechanical or Biomedical Engineering

• 5-8 years of experience in product development for disposable or implantable medical devices focusing on product design and development through commercialization, including a minimum of 3 successful product launches
• Experience in conducting risk analysis, design verifications, and design validations
• Knowledge and experience in product design, material processes, and assembly processes, including injection molding, machining, packaging and sterilization of single-use devices for minimally-invasive procedures

• Working knowledge of the US and international standards governing the design, development and manufacture of medical devices

• Experience developing products or commercial manufacturing under ISO or GMP procedures and associated quality system
• Experience writing documents for submission to the FDA to support clinical testing or marketing approval (e.g. IDE, HDE, 510k, PMA)
• Demonstrated skills in problem solving and applied engineering, including use of statistical tools (e.g., Minitab)
• Applied knowledge of Design Excellence/Design for Six Sigma principles, Design of Experiments (DOE) with associated tools and methods, and Design for Manufacturing
• Familiarity with Human Factors and usability studies and their impact on product development and design
• Team player who enjoys working in a highly dynamic and cross-disciplinary environment
• Excellent written and verbal communication skills

Interested candidates should send an email to

recruiting_wss@arsenalmedical.com

Arsenal Medical, Inc. is an Equal Opportunity Employer. 

BioPharmaceutical Facilities Technician

 Our client, BioPharmaceuticals company has an immediate opening for a Facilities Technician.

Responsibilities:

Position performs a variety of general repairs, installations and maintenance on facility equipment, building and utility systems. Performs analysis of facility / equipment operations and/or processes for continuous improvement in quality, safety and/or efficiencies. Provide support by documentation of maintenance, training, and/or validations business needs.

Qualifications:

• 2 year advanced eduation in facilities maintenance related curriculum or equivalent experience.
• 4+ years experience as Facilities Technician preferably in the pharmaceutical manufacturing/packaging industry.
• Prefer specialized training / certification / license in one or more maintenance disciplines such as refrigeration, HVAC, plumbing / pipe fitting, mechanical repair, hydraulics, pneumatics, etc.
• Should have working knowledge of cGMPs.

Senior R&D Lab Technician

Arsenal Medical is an early-stage, medical device company that is bringing biomaterials systems to the clinic to improve patient outcomes. We are a multi-disciplinary team of biologists, chemists, materials scientists, and engineers, working in close collaboration to create solutions that address some of today’s most challenging and critical unmet medical needs.  Arsenal Medical has created a state-of-the art research and development environment in theBostonmetropolitan area.

We are looking for an experienced Senior R&D Technician to support the design and development of a novel product to treat hemostasis.

Key areas of responsibility

• Assist engineers in the design, manufacture, and testing of medical device.
• Perform routine and non-routine testing to produce reliable and precise data to support product development investigations while following strict methodologies.  Testing to include mechanical properties via Instron, water uptake, laser scanning to generate 3D models and scanning electron microscopy
• Assist in the collection, analysis, and interpretation of data and prepare summaries of laboratory results in graphical and written formats
• Maintain appropriate lab notebook and other records in accordance with FDA and Arsenal standards.
• Install, calibrate, operate and maintain laboratory equipment and machinery; participate in validation of equipment as required
• Under guidance, develop procedures for new test or product development methods and provide suggestions for improvements
• Execute measurement system analyses and gage R&Rs
• Responsible for managing laboratory inventory levels for mechanical parts and chemical inventory.
• Create and/or modify solid model and CAD drawings and fabrication of parts with machine shop equipment.
• Work closely with outside vendors/suppliers to ensure timely and accurate component delivery. Provide training and direction to less experienced technicians/COOPs.
• Participate in team meetings
• Ability to work on multiple tasks related to more than one project.
• May conduct independent research under guidance of senior technical staff.

Qualifications

• High School diploma or GED, 2 year associates degree in life sciences/engineering
• Up to ten (10) years of related experience in a research environment strongly preferred or 8 years with an associate’s degree
• Proficient with basic lab equipment
• Proficient with basic lab skills with the ability to safely work with chemicals
• Prior experience working in a regulated industry under GLP conditions
• Work under the direction of engineering staff with minimal supervision.  Ability to take direction, work independently, manage time, and effectively interact with various groups and personnel.
• Strong skills with computer software including Microsoft Office Applications (Word, Excel, PowerPoint)
• Familiarity with Minitab statistical software a plus
• Demonstrated proficiency in creating and modifying drawing files using SolidWorks or equivalent.  Knowledge of geometric dimensioning and tolerancing preferred.
• Working knowledge of mechanical test methods and product inspection techniques
• Knowledge of transfer from research to pilot, or pilot to commercial manufacturing
• Excellent work ethic with strong attention to detail
• Demonstrated commitment to safety

Position reports to Principal Engineer

Interested candidates should send an email to

recruiting_wss@arsenalmedical.com

Arsenal Medical, Inc. is an Equal Opportunity Employer.