Role Description
The Piscataway Site Technical Operations group is seeking a highly motivated and experienced individual for a Manager, Technical Operations position. The ideal candidate will have extensive hands on experience in the tech transfer and scale up of sterile injectable (includes solutions, lyophilized products, suspensions and emulsions) and ophthalmic pharmaceutical dosage forms (includes solutions, suspensions) and be a subject matter expert in either upstream or downstream practices and operations while also having a fundamental understanding of other areas such as thorough understanding of cGMP, sterile operations etc.

Candidates should have experience in the area of large scale sterile injectable manufacturing. The individual will be expected to provide detailed technical, process understanding and expertise in support of complex technical investigations, process trouble shooting and other highly technical areas for the manufacturing, including technical transfer, scale up, engineering/ANDA/PV and/or commercial batch manufacturing. In such cases they would be responsible for gathering the needed process understanding and history from the appropriate sources and identify and collaborate with other relevant stake holders.

The candidate should be knowledgeable of process equipment and systems, manufacturing operations, and automation control (PLC, Delta V, etc) and will provide the support working with the contract manufacturing organization for coordinating manufacturing activities and troubleshoot complex or unusual problems arising from components, process, equipment and system failures. The candidate should have experience in the area of overall sterile process execution in support of cGMP clinical, engineering, ANDA, PV and /or commercial batch manufacturing.

Candidates should have a strong track record of leveraging collaboration across multiple groups and competing priorities. Proven track record of solving complex issues and leading the implement of robust solutions. Candidate must have extensive understanding and experience dealing with large technical group of engineers, scientist and technicians in large multi-product contract manufacturing facilities.

The individual would be expected to provide support for complex technical projects and in troubleshooting activities serving as the technical lead for the given project. Serve as the operations point of contact for technology transfer and manufacturing.

Potential candidates should have a working knowledge of GMP compliance expectations and conducts all activities that are in accordance with Company policies & SOPs, Pfizer Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc. Advise management of non-conformance issues and opportunities for continuous improvement.

Responsibilities
1.This position acts as Manager, Technical Operations position working in a team environment with Contract Manufacturing Organization to execute processing and operational activities in support of manufacturing of sterile injectable and ophthalmic pharmaceutical dosage forms.
2.Requires detailed knowledge of the technology transfer and scale up. Must be capable of assessing challenges and able to provide technical support to resolve the technical issues during the manufacturing. Able to trouble shoot/recommend the solutions to resolve the technical issues with manufacturing equipment. Able to handle multiple projects simultaneously at different CMOs.
3.Capable of detecting technical manufacturing process problems and assisting the CMOs for the resolution. Ability to collect and assemble applicable, vital information for presentation to assist in troubleshooting and decision making.
4.Able to travel globally, up to 30 % to CMOs for technical meetings, technology transfer, demo/ANDA, PV and/or commercial batches manufacturing.
5.Review and/or approve site technology documents such as tech transfer plans, validation protocols, reports, batch records, sampling protocols, CAPAs, change controls, requirement for the change parts, procedures, policy and instructions, etc.
6.Provide input for investigations, commitments, and change controls assuring changes provide robust manufacturing process - ensures changes are value added.
7.Responsible for working with R & D group in optimizing process parameters of commercial processes within the design space to evaluate/implement opportunities for process improvements. Collaborate with R & D colleagues for required process development and analytical support needed to address process issues and solutions.
8.Participate as needed in reviewing/authoring relevant regulatory and/or technical documents in support of implemented technologies or changes in the manufacturing process and evaluate the impact on the quality of the product
9.Proactively identify challenges and manage their resolution.
10.Guide formulators in developing commercially feasible and scalable sterile products
11.Responsibilities include interaction and collaborate with multiple groups both on site and off site to achieve goals and collaborating with them in review of data and drawing conclusions.
12.Participate in cross-functional teams in the evaluation and implementation of novel manufacturing technology and processes in commercial processes that increase process robustness.
13.The engineer/scientist drives continuous improvement efforts cross- functionally.
14.Drive changes that support right first time, efficiency and effectiveness.
15.Promote a culture of innovation and continuous improvement.
16.Able to work under extreme short time line
17.Improve and manage partner relationship with CMOs.

Qualifications
EDUCATION AND EXPERIENCE
MS or PhD in Science or Process Engineering with 8 + years of experience for an MS or 6 + years with PhD. Candidate must be self-motivating, be capable of driving multiple initiatives simultaneously and able to adapt to rapidly changing project priorities. Grade and title will be commensurate with level of experience

1.Must have at least 6 years of hands on industrial experience in injectable product development, scale-up and technology transfer.
2.The ideal candidate should possess extensive hands on experience in the tech transfer and scale up of injectables (includes solutions, lyophilized products, suspensions and emulsions) and ophthalmic pharmaceutical dosage forms (includes solutions, suspensions).
3.Strong communication skills and writing skills are required as well as the ability to effectively resolve the complex manufacturing process issues and provide the robust solutions.
4.A good team player who has excellent problem-solving and communication skill.
5.Working knowledge of cGMP and regulatory requirement of ANDA filing is preferred.
6.Strong technical and R&D background is desired.

TECHNICAL SKILLS REQUIREMENTS
The Manager, Technical Operations position uses technical knowledge to
* troubleshoot complex or unusual problems arising from components, process equipment and system failures
* lead tech transfer and scale-up activities
* provide investigations support
* analyze process data, and identify and implement process improvements
* Develops and present technical presentations

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Application URL:http://www.aplitrak.com/?adid=c3VzYW4ubS5kaXBhZ2xpYS4wMjU0Ny4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
* The non-physician Clinician is responsible for working collaboratively with the clinical leader, physicians and members of the development team to establish the clinical development plan(s) for one or more compounds from lead development in discovery to Phase I-II clinical trials
* Actively participate in defining the key components of clinical protocols

Responsibilities
* Responsible for formulation of clinical development plans. Will independently design protocols, amendments and conduct data review, analysis and interpretation.
* Performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the safety risk lead.
* Responsible for trial design and supporting the final recommendations on clinical development plan for one or more compounds including review of the pre-clinical package after soliciting appropriate input, review and endorsement from key stakeholders for go no-go development decision criteria.
* In conjunction with the clinical leader, and physicians will prepare strategy presentations, present and discuss data at relevant team, governance, external consultants, Key opinion leaders and potentially regulatory meetings as well as author clinical sections of regulatory documents (IB, Annual Reports, IND sections). This individual must have proven scientific writing skills and good communication skills.
* Will routinely interface with discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations and other members of the extended project team(s).
* Act as liaison with many internal groups, including internal governance, commercial and external experts and potentially regulators.

Qualifications
* Graduate degree in life sciences and breadth of knowledge and experience in clinical research in the academic, or industry setting
* Familiarity with related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
* Demonstrated writing skills (regulatory documents, publications, etc.).
* Experience with clinician role.

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Application URL:http://www.aplitrak.com/?adid=TWVnYW4uSGFycmlnYW4uNTI4MjAuMzE2N0BwZml6ZXIuYXBsaXRyYWsuY29t

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
This position will be part of Pharmaceutical Research and Development within BioTherapeutics Pharmaceutical Sciences. The Scientist will participate in the development of parenteral formulations for biologics modalities such as monoclonal antibodies, antibody drug conjugates, proteins and vaccines. This position will be responsible for performing analytical characterization of candidate formulations by using various biophysical and biochemical characterization techniques. Furthermore this position will assist in developing processes for drug product manufacturing, and is responsible for data compilation, data presentations and report writing.

Responsibilities
The responsibilities of the Scientist position include but are not limited to: participate in developing parenteral formulations for biotherapeutic modalities such as monoclonal antibodies, antibody drug conjugates, proteins and vaccines; help develop manufacturing processes for these parenteral drug products; perform rapid, comprehensive characterization of candidate molecules to determine the stability profile and apply this information to develop an appropriate dosage form to meet clinical needs. This will be achieved by applying various biophysical and biochemical techniques such as HPLC (SE-HPLC, IEX, RP-HPLC), SDS-PAGE, capillary gel electrophoresis (CGE), imaged capillary electrophoresis (iCE), spectroscopy techniques such as UV and fluorescence spectroscopy, circular dichroism and FTIR. The Scientist will assist in the development and scale-up of processes, including lyophilization, from bench top to pilotscale, and, as required, technology transfer to manufacturing plants. The Scientist must be able to interact effectively with a multi-disciplinary team of scientists for formulation optimization and overall candidate progression. This position will be responsible for preparing data summary presentations, compiling data and authoring technical reports. Effective communication skills are desirable for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.

Qualifications
EDUCATIONAL BACKGROUND:
MINIMUM: B.S. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry or equivalent with 6+ years experience

DESIRABLE: M.S in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry or equivalent with 4+ years experience

WORK EXPERIENCE/SKILLS:
MINIMUM: 3 years industrial experience in parenteral formulation and process development of protein, peptide, vaccine, nucleic acid, cell-based or other biologic therapeutics.

DESIRABLE: Knowledge of drug development processes for progression of a biological candidate.

Technical Skills Requirements:
MINIMUM:
- Basic knowledge of protein chemistry, degradation pathways, and stabilization techniques.
- Excellent oral and written communication skills.

DESIRABLE Technical skills:
- Experience with protein analytical methods such as HPLC (SE-HPLC, IEX, RP-HPLC), SDSPAGE, Capillary Gel electrophoresis (CGE), imaged Capillary Electrophoresis (iCE), spectroscopy techniques
- Practical knowledge of lyophilization and lyophilization cycle development is preferred.
- Familiarity with parenteral manufacturing requirements, including media fills, environmental monitoring, container/closure integrity, and commercial unit operations.
- Familiarity with GLP/GMP requirements.
- Familiarity in scale-up and technology transfer to pilot/commercial scale.

Application URL:http://www.aplitrak.com/?adid=amlsbC5jdXR0aW5nLjYxMjExLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ

Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our Regulatory Affairs Department.

• Reporting to the Global Head of RA, LPB and based at Portsmouth, NH the RA Director will support LPB  site and customer related regulatory affairs and CMC project activities at LPB US sites.
• Act as the primary RA contact for LPB within North America
• Work collaboratively with appropriate company personnel to co-ordinate the regulatory work stream elements for CMC activities for LPB products (mammalian fermentation). This will include:
  • preparation and review of scientific and technical information. 
  • drafting of IMPD/INDs and MAA/BLAs
  • support for scientific advice meetings and development of regulatory strategy with customers
  • RoW submission support
• Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions
• Management of the LPB North America  regulatory team covering three sites.
• Internal regulatory support for the control  and operation of RA at the LPB North America sites site.
  • Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of biological, cell and gene therapy  products.
  • Function as the regulatory contact in all direct communication with regulatory agencies
  • Foster good relationships with EU and US regulatory bodies.
  • Support site specific regulatory documents and activities
  • Update Business units and functional leads and maintain transparency of information across regulatory function.
  • Regulatory support deviation and change control activities, as appropriate.
  • Act as the site lead for all regulatory affairs activities
• Maintain documented regulatory project plans in line with best practice recommendations
• Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the LPB  RA team

Required Qualification (Education/Experience):

• Post-graduate qualification in biological sciences, chemistry, biochemistry  or equivalent education and at least 10 years experience in industry or
• Bachelor's degree in biological sciences, chemistry, biochemistry  or equivalent education and at least 15 years experience in industry

  Functional Knowledge:

• At least 10 years of bio-pharmaceutical industry experience of which at least six should include recent relevant regulatory affairs experience  to cover antibodies and mammalian fermentation.
• Understanding of biologics work processes.
• Expertise in the interpretation and communication of CMC regulatory requirements for site product and process issues.
• Working knowledge of US and EU regulatory requirements for biological and cell and genetherapy products.
• Ability to interpret compliance requirements for the creation or review of protocols and site documentation. 

• Excellent understanding of agencies and industry trends across all areas of GXP to anticipate the needs of both the company and the customers and communication of these trends.

• Demonstrated skills managing project timelines;
• Proven recent experience of preparing and authoring IND, NDA/BLA, and CTD submissions for biological products and support for RoW filings
• Proficient with Microsoft Office products;
• Superb organizational skills and attention to detail;
• Demonstrated leadership skills and an ability to manage priorities and work under tight timelines

  Problem Solving Skills:.

• Able to work in a fast paced diverse environment to obtain solutions based on a solid background and understanding of the company procedures, regulatory guidance, current legislation and company and customer objectives.

  Interpersonal Skills:

• Able to communicate a site regulatory compliance philosophy internally and to clients.
• Team player
• Excellent communication and interpersonal skills;.
• Demonstrated ability to work well with cross functional teams.
• Fluent in English
• Willingness to travel

  Skills and Competencies:

• Detail oriented.
• Ability to review and critique complex technical documents.
• Strong influencing skills.
• Strategic approach and system oriented toward goals and objectives.
• Strong results orientation.
• Ability to represent the company on regulatory issues both internally and externally.
• Strong interpersonal and leadership skills with the ability to interact positively with all functions •           
• Excellent team leader as well as committed team member
• Strong written and verbal communication; ability to present to various audiences’ levels.

An Equal Opportunity Employer

      M/F/Disability/Veterans

 Please take virtual tour of the Portsmouth, NH site.

Click here http://lonzavirtualtours.com/

Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our Validation Department.

• Responsible for executing and enhancing equipment and utility qualification/validation, cleaning validation, and computer system validation (except for QC laboratory equipment) programs at a large scale, multi-product, GMP biotech contract manufacturing facility.
• Ensures that systems and controls for the above activities meet Global Quality standards and applicable regulatory requirements.
• Managing and planning the work of the entire department.  Assessing workload and managing resource deployment to achieve validation goals.  Responsible for managing and tracking execution of validation activities versus project timelines.
• Develop validation master plans, validation protocols, and project plans.  Review completed protocols/reports for completeness, cGMP compliance and acceptability of data.
• Liaise with clients to ensure that scope, execution and reporting of validation meets their expectations.
• Participate as required in Regulatory Inspections and client audits.
• Selects, trains, and supervises staff to perform functions consistent with procedural and business requirements.  Develops, mentors, and coaches direct reports.
• Determines and manages resource requirements to support operations in areas of responsibility.  Develops annual budget for group and manages expenses to budget.

BS Science or Engineering related field

Validation in a cGMP environment (obligatory) 10 years

Management of validation teams (obligatory) 5 years

Wide range of equipment qualification/validation, especially biotechnology (obligatory) 5 years

Cleaning validation (obligatory) 5 years

Sanitization Sterilization experience (obligatory) 5 years

Process Validation (advantageous)

Computerized Systems Validation/Part 11 Compliance (obligatory) 1 year

Large scale pharmaceutical/biotech facility commissioning/validation (advantageous)

KNOWLEDGE: 

• Thorough understanding of cGMPs and life cycle approach to qualification/validation.  Understanding and experience with facility design, startup, commissioning and qualification/validation.  Experience in the practical and theoretical requirements of validation projects, including facilities, process equipment, utilities, equipment cleaning and computerized systems. 

SKILLS: 

• Demonstrated strong ability in problem solving, strong understanding of cGMPs, excellent interpersonal skills and the ability to prioritize multiple tasks. Must be able to act decisively.
• Uses a team-oriented approach to project management and problem resolution.
• Excellent understanding of validation/qualification principles, industry practices, and standards with demonstrated ability to apply these to GMP operations.
• Ability to work both independently and collaboratively in a team structure.  Holds self and others accountable ion achieving collective goals.
• Excellent verbal and written communication skills, including the ability to influence others and lead complex projects.  Successful interactions with regulatory agency staff and customers desirable.
• Working knowledge of manufacturing processes, validation, and change control concepts for pharmaceutical manufacturing.
• Strong attention to detail with strong documentation and coordination practices.
• Demonstrated ability to multi-task and manage competing priorities.
• Demonstrated ability to lead GMP operations, make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA oversight.
• Demonstrated strength as a manager including mentoring and coaching of staff, establishing priorities, and delivering on projects within budget and on time.

An Equal Opportunity Employer

      M/F/Disability/Veterans

QC Associate responsibilities include: HPLC, routine testing, wet chemistry, analyzing data and general lab duties.    BS degree in Chemistry, Biochemistry or other related scientific discipline w/0-2 years experience. 

Job Description

Job title: Director, Regulatory Affairs

Reports to: Vice President, Regulatory Affairs

Key Responsibilities

- Execution of global registration strategies for all pipeline products and support activities in the therapeutic area of the central nervous system.

- Assisting in the design and analysis of Clinical Studies to support Regulatory Approvals.

- Review and approval of promotional, advertising, and labeling items.

- The preparation and submission of Clinical Trial Applications (CTAs), Investigational Medicinal Product Dossiers (IMPD), Investigational New Drug Applications (IND) and other submissions, as required. Ensuring that licenses of products are maintained and defended in appropriate markets by providing regulatory expertise (data, information, advice). 

- Representing the Company at meetings with Regulatory Authorities.

- Securing close regulatory interactions globally throughout the lifecycle of pipeline projects to secure the development of appropriate development plans, Pediatric Investigational Plans (PIPs), Liaising closely with commercialization partners and support the launch and roll out of products in partner territories.

- Following the emergence of new regulatory requirements including analyzing new and emerging requirements and assessing their impact on the development pipeline.

- Providing counsel, training, and interpretation of global regulatory agencies and other regulatory issues to Company personnel and assisting as a liaison between the Company and Regulatory Authorities.

- Participation in industry association committees and initiatives as a scientific expert, as appropriate, to represent and defend the Company’s interests.

- Developing and maintaining contacts with global Regulatory Authorities to represent and defend the company’s interests and the building of a regulatory network of competent partners.

Qualifications

- 8-10+ years of Regulatory Affairs experience, Bachelor or a higher scientific degree (MS, PharmD, PhD).

- 5-10+ regulatory experience in the biotech/pharmaceutical industry in both the pre-market and post-market setting.

- 5-10+ years experience in therapeutic products (preferably biologics/vaccines/advanced therapeutics).

- Experienced in leading EU Regulatory Agency meetings resulting in successful regulatory approvals, including product defense experience for products marketed in the EU.

- Experience with international regulatory submissions and an understanding of worldwide drug and biologics guidelines and regulations.

Core competencies

- Demonstrated people management experience, and development/growth and retention of talented personnel, differentiating performance and rewarding accordingly.

- Excellent oral and written communication skills - invaluable in communicating with global, cross functional, cross-cultural, multi-disciplinary project teams including team members in country offices.

- Experienced in communicating vertically and horizontally within an organization and with necessary cultural awareness and sensitivity.

- Respectful and collaborative team player with both line and matrix management experience

- Ability to rapidly understand and analyze complex problems/situations; active participation and the management of projects leading to solution development and implementation.

- Record of influencing project teams, strategically, operationally and delivering on budget and within agreed upon timelines.

- Involved in implementing and optimizing corporate strategies globally, thinking creatively outside the box, while ensuring transparency and clear decision-making.

 OBJECTIVE:

• Support commercial organization with primary responsibility for drafting commercial contracts and providing legal guidance
• Provide legal support and guidance for marketed oncology products
• Responsibility for managing state and distribution license requirements
• Legal representative for assigned cross-functional initiatives 

• Proactively provide legal and strategic guidance to Oncology Business Unit on the structuring of business arrangements in compliance with applicable law
• Proactively coordinate with legal colleagues globally to stay abreast of pharmaceutical laws and regulations, in particular, with respect to the marketing and sale of oncology products and related companion/diagnostic products.
• May have responsibility for coaching or supervising paralegals and support staff on individual projects.
• Develop a thorough understanding of and familiarity with the company’s business, its people, products, markets, facilities, customers and competitors and utilizes that knowledge in providing guidance and counsel to internal clients.
• Establish a rapport and a working relationship with Oncology Business Unit management and personnel at all levels to encourage and continue the proactive use of in-house legal counsel.
• Identify training needs within the organization and assist in the development and presentation of training materials on relevant laws and legal/business issues.
• Identify and assign, as well as perform special assignments or projects, with supervision, as assigned by senior attorneys.
• Additional duties as assigned.

Qualifications 

• Licensed to practice law in Massachusetts

• 15% travel required 

we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

Job Description

Job title: Manager, Regulatory Affairs

Reports to: Director, Regulatory Affairs

Key Responsibilities 

- Supports execution of global registration and clinical development strategies for all pipeline products and support activities.

- Assisting in the global submissions for early and pivotal clinical studies to support regulatory approvals.

- Reviews promotional, advertising, and labeling items.

- Responsible for preparation/submission/maintenance of current and future MAA and IND/IMPD (including variations, amendments, annual reassessment) and Scientific Advice and FDA meetings for all pipeline products and support activities.

- Maintaining regulatory files and records of contact with Regulatory Authorities

- Advises all Clinical related and CMC related departments (Clinical Operations, Process Development, Analytical Development, manufacturing and Quality Control) on the preparation and content of IMPDs, INDs and MAA dossiers to ensure timely delivery of final documents to be included in submissions.

- Supporting close regulatory interactions globally throughout the lifecycle of pipeline projects to secure the development of appropriate development plans, Pediatric Investigational Plans (PIPs) and registration strategies etc.

- Following the emergence of new regulatory requirements including analyzing new and emerging requirements and assessing their impact on the development pipeline.

- Maintain an up-to-date knowledge of the relevant (EU, US and ICH) regulations, pharmacopoeias, guidelines and gain regulatory intelligence by visiting relevant meetings and conferences.

Qualifications

- 5-8 years of Regulatory Affairs experience with in the biotech/pharmaceutical industry in both the pre-market and post-market setting.

- Bachelor or a higher scientific degree (MS)

- Experience in biologics/vaccines/gene therapeutics preferred.

- Experience with international regulatory submissions and an understanding of worldwide drug and biologics guidelines and regulations.

- Specific experience with CMC and facilities desired

Core competencies

- Demonstrated people management experience, and development/growth and retention of talented personnel, differentiating performance and rewarding accordingly.

- Excellent oral and written communication skills - invaluable in communicating with global, cross functional, cross-cultural, multi-disciplinary project teams including team members in country offices.

- Experienced in communicating vertically and horizontally within an organization and with necessary cultural awareness and sensitivity.

- Respectful and collaborative team player with both line and matrix management experience

- Ability to rapidly understand and analyze complex problems/situations; active participation and the management of projects leading to solution development and implementation.

- Record of influencing project teams, strategically, operationally and delivering on budget and within agreed upon timelines.

- Involved in implementing corporate strategies globally, thinking creatively outside the box, while ensuring transparency and execution of clear decision-making.

Job Description

Job title: Senior Associate, Regulatory Affairs

Reports to (Position): Director, Regulatory Affairs

Key Responsibilities 

- Participates in the preparation of documentation packages for Regulatory submissions (including IND, CTA, BLA, etc.) to the FDA, and other Regulatory Agencies

- Edits, coordinates and reviews regulatory documentation for inclusion in INDs, CTAs, BLAs, and other worldwide submissions

- Compiles documentation for submissions to FDA and foreign Regulatory agencies

- Contributes to the further development of the Regulatory Operations infrastructure regarding documentation preparation and electronic submissions including vendor selection and management

- Develops and maintains current regulatory knowledge and implements the changes required for Regulatory compliance

- Maintains Regulatory documentation including submissions to and correspondence with each governing authority

- Coordinates collection of information from other departments (Quality Assurance, Clinical Operations, Operations and CMC, etc.) for implementation in Regulatory submissions and maintains the established project plan for submission deadlines.

- Performs other appropriate administrative duties, such as preparing correspondence and filing, where necessary

- Maintains chronological and operational trackers for submissions and records of contact

- Other duties as required

Qualifications

- 5+ years’ experience in Pharmaceutical/Biotech Industry, to include a minimum of 3 years’ experience in a Regulatory Affairs/Regulatory Operations capacity

- Experience in biologics/vaccines/gene therapeutics preferred.

- Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD, and global regulatory requirements for the marketing authorization application process

- Previous participation in preparing Regulatory submissions (IND, CTA, BLA, etc.) to the FDA and EU Regulatory Authorities

- Solid understanding of the e-CTD specifications for electronic submissions

- Experience working with and implementing electronic tools used for submissions a plus

- Strong technical writing ability and previous experience in documentation preparation/publishing using Adobe Acrobat, preferred

- MS Office Expertise: Outlook, Word, Excel, PowerPoint, Project, Visio

Core competencies

- Excellent oral and written communication skills and time management skills - invaluable in communicating with global, cross functional, cross-cultural, multi-disciplinary project teams including team members in country offices.

- Ability to handle matters of strict confidentiality and sensitivity

- Respectful and collaborative team player.

- Ability to understand and analyze problems/situations; active participation and strong attention to detail, organized, and dependable

Overview:

The Commercial Manufacturing Operations role is a pivotal part of our commercial team and will be instrumental in supporting product manufacture. This chosen candidate must be ready for the challenges, responsibilities and rewards that come from working in a high-energy, fast-paced environment. He/She will be responsible for Commercial Manufacturing and Packaging/Labeling of solid dosage form products at contract manufacturing organizations (CMOs). He/She will participate as a member of the cross-functional leadership group responsible for ensuring Collegium’s products are manufactured in accordance with strategy based on capacity analysis and regulatory assessment, business plans and the highest standards of compliance. He/She must be able to function in a rapidly evolving environment, be willing to multitask and take on additional responsibilities as necessary.

Responsibilities:

• Oversee, lead and direct all CMO manufacturing activities and supply chain requirements to ensure products are manufactured and packaged according to approved procedures in support of the commercial forecast.
• Act as the primary contact for communications and resolution of manufacturing, inventory, supply chain and technical issues that may impact timely supply of product and/or contractual obligations.
• Manage the business, operations, and quality objectives, milestones and activities of the CMO relationship.
• Review and approve change controls and Master Batch Records.
• Ensure that all manufacturing and packaging SOPs are kept up to date and reflect current regulatory requirements.
• Ensure that all planned continued process verification activities with validation and commercial batches are implemented in a timely manner
• Lead the selection, implementation and management of commercial contract manufacturing organizations (CMO).
• Lead, develop and negotiate supply contracts
• Prepare, negotiate, and maintain commercial Requests for Proposals (RFP), Term Sheets, Supply Agreements, Amendments, Master Services Agreements (MSA), and Quality agreements.
• Manage and drive continuous improvement in Collegium’s overall relationships with CMOs and/or business partners.
• Manage risk assessment process to avoid or minimize risks that may impact supply. Lead efforts to manage and execute risk mitigation plans.
• Prepare quarterly operations reviews and reports to communicate performance status of CMO's and overall product supply chain, metrics, key issues and highlights for senior management.
• Serve as a subject matter expert in support of department functions and mentor junior personnel.

• B.A., B.S. or M.S. degree in Life Sciences, Engineering or Business.
• 15+ years of relevant experience in the pharmaceutical industry or an equivalent combination of education and experience.
• Experience with small molecule manufacturing, labeling, packaging, and/or distribution.
• Demonstrated ability to lead/direct and work in cross-functional, cross-enterprise project teams.
• Subject Matter expert of manufacturing operations, supply chain management, and processes.
• Demonstrated ability to negotiate and develop contracts with minimal guidance.
• Strong ability to lead strategic outsourcing, business, operations and quality decisions.
• Demonstrated project management skills
• Strong analytical and creative problem solving skills.
• Strong quality orientation with extensive knowledge of GMPs, FDA regulatory guidelines and validation practices.
• Effective communicator at all levels; excellent written, oral and interpersonal communications and presentation skills.
• International and domestic travel estimated at 25%.

Overview:

• Perform all phases of clinical site management from site identification and qualification through site closure to ensure the integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records.
• Ensure documentation at study sites are maintained according to FDA regulations and ICH-GCP guidelines, and collect copies of essential documents for the trial master file, as defined in sponsor SOPs and the clinical monitoring plan.
• Develop and maintain collaborative relationships with study sites, providing information to these sites on a regular basis and answering questions from study coordinators and investigators as they arise.
• Assist in the preparation of study manuals, informed consent forms, and case report forms as well as the organization and shipping of all clinical trial supplies to study sites.
• Complete clear, concise monitoring visit reports, telephone contact reports, and follow-up letters in a timely manner and according to the clinical monitoring plan.
• Document protocol deviations.
• Assist in data review prior to database lock, as needed.
• Perform other clinical trial duties, depending on experience level, such as protocol writing and project management activities.

The ideal candidate will have:

• Bachelor’s degree and at least 3 years of clinical research experience, including at least 1 year of independent monitoring at a sponsor or CRO
• Demonstrated working knowledge of ICH-GCP guidelines and FDA regulations
• Strong attention to detail
• Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting
• Proven flexibility and adaptability
• Good organizational and time management skills
• Excellent verbal and written communication skills as well as effective interpersonal skills

I currently have an awesome opportunity to build a biotherapeutic screening platform for a well established client here in Boston. Ideally you will have a strong background in Cellular Pharmacology and in high-content screening (HCS) for immunology based therapeutic programs. This expert will be able to adapt assay as well in various formats (cell proliferation, apoptosis, differentiation, internalization, intracellular) and technologies including Flow Cytometry, Ion Channel, GPCR assay design for various therapeutic indications. This new group will rely on this expert to build capabilities and be the go-to expert for novel assay design, optimization, and development activities.

Are you a hands on type that can take on the variety of challenges this group will face in delivering advance biotherpeutic programs? Our client is seeking a top technical member of their team to help bring in an innovative and creative strategies.  Don't miss this chance to advance your expertise today with a great group.
Required and Desired Skills:

• Ph.D. in Cellular Pharmacology, Biochemistry, or Immunology with 5+ years industry experience
• High Content Screening and High Throughput Screening expertise.
• Experience in Flow Cytometry and B Cell Screening.
• Problem solving collaborative nature to take on all challenges to help the team in successful assay development.

About StratAcuity
Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

A Clinical Trial Associate (CTA) is required to help support Clinical Operations and study/project teams. The position offers much responsibility and the opportunity to be involved in all phases of the clinical project. The position requires adaptability and the capacity to ‘own’ tasks, problem solve and to see activities through to their end.

Responsibilities to include:

• Assists with preparation of all external and internal documentation, for assigned trials, to ensure such documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocol, under close supervision
• Communicate with the study teams (Sponsor, CRAs, vendors, etc.); will assist in the planning, organizing and execution of study-specific meetings, writing and distributing meeting minutes.
• Assists Clinical Trial Managers in site management activities which could include review of monitoring reports, tracking of site visits, communication with monitors and sites, and other activities as assigned
• Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and Case Report Forms
• Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File within established guidelines
• May participate in the training of CRO teams, investigators and staff as needed regarding assigned logistics of the clinical trial
• Tracks delivery and receipt of required supplies and materials to study sites and provides regular status updates

• Maintains biological sample tracking procedures and systems
• Will prepare correspondence, spreadsheets and presentations for projects/studies.
• May be assigned co-monitoring responsibilities; primarily local and occasional travel may be required.
• Other duties as assigned.

Job Requirements

• Demonstrates a working knowledge of ICH GCP regulations and clinical protocols
• Exhibits ability to ‘multi-task’ effectively
• Ability to interact well with various team members and provide value added support to project
• Displays ability to independently solve routine problems following standard policies/procedures

Who You Are

• Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study, preferred; experience as Clinical Research Associate (CRA) is a plus
• Minimum of 3 years clinical trial experience as Clinical Trial Associate
• Familiarity with GCPs, ICH guidelines and FDA regulations
• Familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements is a plus
• Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

ACCOUNTING MANAGER – OXFORD, UK

Job Summary

 OvaScience is looking to hire an experienced hands-on Accounting Manager who is an enthusiastic, strong leader with a solid technical accounting background to join our team in Oxford, UK.

 Essential Functions and Duties

•  Manage the accounting and reporting function consisting of the monthly closing and consolidation process, general ledger, cash receipts and cash disbursements
• Prepare monthly intercompany journal entries and reconcilations for multiple entities
• Ensure that the close process is streamlined and that the roles and responsibilities of those involved are appropriate; Recommend and implement any changes necessary to improve the process
• Create the majority of OvaScience Limited internal financial reports
• Assist in the development of external reports including statutory reporting requirements
• Prepare technical accounting memos
• Maintain and ensure ongoing compliance with accounting policies and procedures including Sarbanes-Oxley (SOX) internal control documentation
• Work with the Sr. Director, Global Finance & Operations on preparing and reviewing journal entries, balance sheet reconciliations/reviews and internal control work
• Manage Office Manager in processing accounts payable and accounts receivable
• Ensure compliance with Corporate finance initiatives and reporting deadlines

Education and Experience

• BA/BS in      Accounting or Finance
• Chartered      Accountant (CPA a plus)
• 4-6 years of      relevant experience, including:
  • 3 - 4 years public       auditing experience
  • 1 - 3 years       industry experience including experience as an accounting manager
  • Experience  in a public company strongly preferred
  • Supervisory       experience desired but not required

Knowledge, Skills and Abilities

• Exceptional  judgment in prioritizing and making scheduling decisions
• Strong attention   to detail with excellent verbal and written communications skills
• Ability to  maintain a high level of confidentiality and professionalism
• Experience with international accounting, intercompany transactions and revenue accounting
• Very strong computer skills in Excel and MS office products
• Life Science Industry experience is a plus

• Experience with a public company listed on a United States stock exchange a plus

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

 The Antibody purification group within Process and Analytical Development is seeking a highly motivated candidate for a Research Associate I/II or Engineer I/II position. The successful candidate will work with members of the group to develop early and late stage Antibody Purification processes. This person is responsible for supporting process development, process improvement and process characterization studies. This position offers the opportunity to interact with other groups across different functional areas within the company. The role will provide an excellent growth opportunity for candidates interested in pursuing a process development career.

 Responsibilities include, but not limited to, the following:

• Good knowledge of protein chemistry.
• Design and Execution of experiments to develop antibody purification processes.
• Analysis of antibodies and process/product related impurities using the latest analytical techniques such as CE-SDS and HPLC.
• Preparation of written and oral reports.
• Work within a multifunctional team to produce quality products.

Who You Are

• The qualified candidate possesses a BS in Biology, Biochemistry, or Bio-or Chemical Engineering with 0-5 years of relevant experience or a MS with 0-3 years of experience.
• Relevant experience would include knowledge of protein chemistry, protein purification and protein analytics (e.g. HPLC- and UV-based assays).
• Good organizational, communication and documentation skills are necessary.
• PhDs will not be considered for this role.

*Applicants must have unrestricted authorization to work in the United States

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

Associate III sought to independently develop and implement analytical methods used in release and characterization of antibody-drug conjugate (ADC) products. The selected individual will support development, planning and execution of analytical strategy in collaboration with department colleagues and with Chemistry, Manufacturing and Controls (CMC) project teams.

Key Responsibilities Include:

• Experience with chromatographic methods for proteins analysis such as RP, SEC, IEX, HIC and capillary electrophoresis, including, CE SDS, ICIEF, CIEF and CZE.
• Summarize data, perform graphical and statistical analysis, interpret and present data.
• Author standard operating procedures (SOPs), technical reports and memos.
• Assist in the design of and perform experiments.

Who You Are

• Bachelor’s degree or equivalent in Chemistry, Biochemistry, Pharmaceutical Sciences or related field with a minimum of four years of work experience in the job offered or related fields of Chemistry, Biochemistry or Pharmaceutical Sciences OR Master’s degree or equivalent and two years of work experience.
• Must have knowledge and a background developing, setting up and executing analytical methods for proteins and the drafting of technical memos and reports.
• Track record of working successfully in cross functional teams

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

The Antibody purification group within Process and Analytical Development is seeking a highly motivated candidate for a Scientist I or Senior Engineering position. The successful candidate will work with members of the group to develop early and late stage Antibody Purification processes. This person is responsible for process development, process improvement, process characterization, process transfer and technology improvements. The position will report directly to the group leader and offers the opportunity to interact with other groups across different functional areas within the company.

Responsibilities include, but not limited to, the following:

• Significant knowledge of protein chemistry and protein purification
• Hands on experience in protein purification techniques, such as chromatography, filtration and untrafiltation
• Hands on experience on analytical techniques, such as HPLC, UPLC and CE-SDS (Gel chip)
• Able to use statistical approach for process development
• Drive the development and implementation of new techniques and apply them to process development and science and engineering excellence
• Good communication skills including good writing skills, such as technical reports, regulatory documents and support documents (e.g change controls)
• Willing to present at external conference and track record of doing this in past roles
• Must be a good team player, capable of interaction with different functional groups within the company and outside CMO
• Willingness for occasional travel (domestic and international) up to 10%

Who You Are

• The qualified candidate possesses a Ph.D in Biochemistry, or Bio/ Chemical Engineering with 0-5 years of relevant experience or a MS with 5-8 years of experience.
• Relevant experience would include significant knowledge of protein chemistry, protein purification and protein analytics (e.g. HPLC- and UV-based assays).
• Demonstrated ability to drive scientific excellence, with noteworthy publication experience.
• Strong organizational, communication and documentation skills are necessary in dynamic high growth organizations

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

The Clinical Trial Manager is accountable for leading or supporting the planning, execution and reporting of clinical trials, within budget and in compliance with company processes and regulatory requirements. This role liaises with vendors and partners as needed, directing CRO management and oversight of outsourced clinical activities. The successful candidate will be a reliable team player that has the ability to work well with many different functional areas including regulatory affairs, compliance, program management, medical/clinical sciences, data management and drug supply.

Responsibilities to include:

• Overall operational planning and activities for the implementation and conduct of clinical trials
• Manage the supervision of contracted clinical research organizations, clinical laboratory vendors, and other outsourced work
• Contribute to vendor selection and management including issue escalation
• Lead both an internal and external/CRO trial management team, to ensure the successful conduct in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
• Contribute to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team
• Ensure Clinical Operations team and external partner receive trial specific training
• Report key trial performance information, including start-up metrics, enrollment, data collection timeliness/quality
• Author and review as needed clinical trial documents (Informed Consent Forms, Clinical Trial Plans, Case Report Forms, Statistical Analysis Plan, etc.). Review and contribute as needed to Investigator’s Brochure and other supportive regulatory documents
• Manage assigned aspects of the budget, timelines, and risk mitigation processes with input from key stakeholders
• Support the development and application of standardized operational processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness
• Support the management, oversight (CRO) and maintenance of the Trial Master File (TMF)
• Ensure inspection readiness at all times

Who You Are

• Bachelor of Science Degree, preferably in Life Science, Physical Science, Nursing or Biological Science, with approximately 5 years of progressively increasing clinical research experience within the pharmaceutical/CRO industry.
• Requires depth and/or breadth of expertise in clinical research (Oncology/Hematology a plus)
• Demonstrated experience in clinical trial management with thorough knowledge of drug development regulations, ie: FDA GCP/ICH regulatory guidelines
• Experience cultivating and maintaining relationships with internal and external colleagues and partners, and track record of working cross functionally for operational effeciency
• Experience in trial resource planning, budgeting, and timeline setting to meet the company needs
• Experience anticipating and addressing key technical and operational problems in clinical research that could impact the broader process or team
• Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc. Clinical trial management system (CTMS) background is a plus
• Demonstrated communication skills with the ability to communicate in a clear, open and effective manne
• Demonstrated organizational and time management skills in fast paced, high growth organizations
• Demonstrated ability to prepare and deliver verbal presentations which are clear, focused and concise

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

The Analytical & Pharmaceutical Sciences Associate will play an important role in advancing ImmunoGen’s key development programs as well as, oversee the commercialization of our Antibody Drug Conjugates (ADCs) as the final goal.  The Analytical Associate will play a key role in the department developing and helping to implement analytical methods to be used in the release and characterization testing of our ADC products.  The Analytical Associate will also assist in the development of novel formulations for our ADC products by developing stability indicating methods, testing stability samples and supporting drug product development. An important role of an Analytical Associate involves helping to support the development of antibody and ADC manufacturing processes by providing the needed analytical and characterization data required to support these efforts.

Responsibilities include, but are not limited to, the following:

•  Develop and qualify analytical methods for the release and characterization of ADCs
• Troubleshoot analytical methods and instrumentation
• Transfer methods as appropriate to CMO, CRO and QC groups
• Support ADC formulation development by testing appropriate development and forced degradation samples
• Provide analytical support to drug product development teams working with partners and CMOs
• Summarize data, draft and review technical reports
• Represent the department as needed at interdisciplinary meetings either internally or with external partners and CMOs

Who You Are

Degree in Chemistry, Biochemistry or Pharmaceutical Sciences or related field.  Master of Science (MS) with 0-4 years or Bachelor of Science (BS) with 2-6 years of related experience performing analytical and formulation development in the biopharmaceutical industry.

• Expertise in the development and performance of chromatographic analytical methods (e.g. RP, SEC and IEX HPLC/UPLC).
• Experience using UV and fluorescence spectroscopy to analyze proteins.
•  Team player with excellent oral and written communication skills.
• Demonstrated ability to function and lead in a collaborative team.
• Multitasking, ability to prioritize tasks, manage risks, and solve challenging technical problems

Additional desired skills:

•  Experience performing capillary electrophoresis (e.g. CIEF, CZE and CE-SDS).
• Thorough knowledge of protein chemistry and common techniques for protein characterization (e.g. N-glycan mapping, peptide mapping).
• Experience formulating or assisting with formulation of proteins, especially monoclonal antibodies (e.g. formulation stability studies, forced degradation studies, freeze/thaw studies etc.)

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

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