My biopharma client, focused on bridging the gap and advancing treatments to patients within the rare disease space, is seeking a talented and motivated Regulatory Affairs professional with an entrepreneurial spirit.  Located in Cambridge, this position is looking for someone with expertise in biologics and/or small molecule that can manage regulatory submissions both internally and externally.  If you are a team player that thrives in a small, yet growing business environment, then read on.
REQUIREMENTS:
•    BS/MA (in biology) with 5+ years biotech experience or PhD with 3+ years’ experience
•    Proven ability to draft and review regulatory documents
•    Experience in managing structured rounds of review of key documents
•    Able to build relationships with third parties and vendors
•    Exceptional technical review and writing skills

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™

Work with business units, such as HR, R&D and business development, to design and execute visual and written communications, presentations, and web interfaces for internal and external use. Project work varies based on emerging needs but can be things like assistance with conference materials, internal communications/intranet, and internal branding.

BA/BFA in design with a focus on commercial/corporate design

Masters in Computer Science, Mathematics, Statistics, or Engineering  Proficiency in machine learning, datamining, and statistical pattern recognition Capable R or Python developer Experience designing and developing static and dynamic visualizations (e.g. ggplot2, d3.js) Familiarity with statistics and analytics An interest in immunology and cellular biology Strong quantitative, analytic and problem-solving skills Ability to communicate with the research team, obtain requirements, find solutions and implement them in a clean and concise way Experience with version control (git) and working in a team Passion for innovation and building systems from the ground up Ability to adapt to an ever-changing environmentA/BFA in design with a focus on commercial/corporate design

Must be comfortable working with in a scientific space and/or have a willingness to learn enough of the main Agenus concepts to help articulate our message. Successful candidate will need to present a portfolio of work

Work with business units, such as HR, R&D and business development, to design and execute visual and written communications, presentations, and web interfaces for internal and external use. Project work varies based on emerging needs but can be things like assistance with conference materials, internal communications/intranet, and internal branding.

BA/BFA in design with a focus on commercial/corporate design

Masters in Computer Science, Mathematics, Statistics, or Engineering  Proficiency in machine learning, datamining, and statistical pattern recognition Capable R or Python developer Experience designing and developing static and dynamic visualizations (e.g. ggplot2, d3.js) Familiarity with statistics and analytics An interest in immunology and cellular biology Strong quantitative, analytic and problem-solving skills Ability to communicate with the research team, obtain requirements, find solutions and implement them in a clean and concise way Experience with version control (git) and working in a team Passion for innovation and building systems from the ground up Ability to adapt to an ever-changing environmentA/BFA in design with a focus on commercial/corporate design

Must be comfortable working with in a scientific space and/or have a willingness to learn enough of the main Agenus concepts to help articulate our message. Successful candidate will need to present a portfolio of work

Work with business units, such as HR, R&D and business development, to design and execute visual and written communications, presentations, and web interfaces for internal and external use. Project work varies based on emerging needs but can be things like assistance with conference materials, internal communications/intranet, and internal branding.

BA/BFA in design with a focus on commercial/corporate design

Masters in Computer Science, Mathematics, Statistics, or Engineering  Proficiency in machine learning, datamining, and statistical pattern recognition Capable R or Python developer Experience designing and developing static and dynamic visualizations (e.g. ggplot2, d3.js) Familiarity with statistics and analytics An interest in immunology and cellular biology Strong quantitative, analytic and problem-solving skills Ability to communicate with the research team, obtain requirements, find solutions and implement them in a clean and concise way Experience with version control (git) and working in a team Passion for innovation and building systems from the ground up Ability to adapt to an ever-changing environmentA/BFA in design with a focus on commercial/corporate design

Must be comfortable working with in a scientific space and/or have a willingness to learn enough of the main Agenus concepts to help articulate our message. Successful candidate will need to present a portfolio of work

T2 Biosystems, founded in 2006 by renowned scientists from MIT and Mass General Hospital, is an in vitro diagnostic company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies.     We are using our T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier.  T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets as limits of detection as low as one colony forming unit per milliliter, or CFU/ml.  Our initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. We have completed a pivotal clinical trial for our T2Dx diagnostic instrument, or T2Dx, and T2 Candida panel, or T2Candida, which have the ability to rapidly identify the five clinically relevant species of Candida, a fungal pathogen known to cause sepsis.

On September 22, 2014, T2 Biosystems received market authorization from the U.S. Food and Drug Administration (FDA) for its first two products, the T2Candida® Panel and the T2Dx® Instrument for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. T2Candida and T2Dx, for the first time, provide sensitive detection of specific sepsis-causing pathogens directly from a whole blood specimen in approximately four hours. All other currently FDA-cleared detection systems require cultured blood samples for species-specific identification and take two to five days or more to provide results.

T2 Biosystems was named to the FierceMedicalDevices "Fierce 15" list in 2012, received the prestigious SBANE award in 2013 and received the Most Promising Company award at the Personalized Medicine World Conference in 2014.

We are seeking a talented and highly motivated individual to join our team as a Senior Quality Assurance Analyst .

Summary: 

• Responsible for supporting the quality assurance department promoting product quality and quality system compliance consistent with T2 Biosystems’ company goals including the direction, planning and execution of quality improvement initiatives.
• Supports the establishment and maintenance of the Quality System in compliance with QSR, EN ISO, and IVDD regulations. Manages multiple programs, and interfaces with a variety of internal and external stakeholders.

Duties &Responsibilities:

• Technical writing to support required Quality Management System documentation.
• Conduct internal audits and support timely completion of audit findings. 
• Work with teams to define and develop action plans and support timely closure of Corrective and Preventative Actions (CAPA).
• Generate quality reports that track cycle times, yields/quality rates, and evaluate trends through Pareto charts for various quality system and product performance metrics.
• Perform supplier assessments and improve supplier monitoring through improved trending, scorecards, and reports.
• With the R&D team define a comprehensive risk management plan for development activities in accordance with ISO 14971.
• Develop IQ, OQ and PQ protocols for measurement, test, quality system and manufacturing equipment/software; execute protocols and generate reports as necessary.
• Troubleshoot process problems, define root causes, coordinate implementation of corrective actions and verify corrective action effectiveness.
• Utilize quality principles and problem solving skills (risk analysis, statistical techniques, etc.) to address product design and manufacturing issues.
• Support process and product-related deviation activities including tracking and trending.
• Disposition, process, and track non-conforming material reports (NCMRs).
• Support complaint investigation, record keeping and trend reporting.
• Review Quality System records for conformance to specified requirements.

Required Experience:

• BS in related Life Sciences
• ASQ or six Sigma certification or equivalent is desired
• 8+ years in the medical device industry serving in Quality Assurance function.  Experience with In Vitro Diagnostic products preferred.
• Extensive experience in Quality Systems compliant with EN ISO 13485, ISO 14971, IVDD, and 21CFR Part 820.
• Technical writing with strong work processing proficiency
• Statistical sampling and data analysis, strong proficiency with Microsoft Excel. 
• Ability to define problems, collect data, establish facts, and draw valid statistical conclusions. 
• Knowledge of inspection techniques and equipment

 Additional Attributes:

• A team player adept at working collaboratively in an R&D environment.
• Excellent organizational skills,
• A strong work ethic to generate high quality work under tight deadlines,
• A proactive attitude,
• Excellent communications skills (oral and written); proven ability to deal effectively with clinical practice thought leaders; effective communications to superior, peer and subordinate levels.
• Strong organizational and interpersonal skills.
• Demonstrable project management and creative problem solving skills.
• Preferred experience design controls, assay, and device manufacturing.

To apply, please follow the link to our careers page at: http://www.t2biosystems.com/careers/

T2 Biosystems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.

The individual in this role will conduct quality scientific analytical experimentation to support development of robust formulations. He/she will develop and validate analytical methods with minimal guidance.  Knowledge of standard analytical chemistry techniques common to small molecule pharmaceutical development, particularly HPLC analysis, is required.  The successful candidate will work effectively independently, but also be capable and willing to oversee the work of more junior staff on an as needed basis.  Knowledge of cGMP and other relevant regulations is required.

• With minimal guidance, executes the development, validation and transfer of analytical methods and the testing of drug products, including but not limited to dissolution, assay, and impurities.
• Supports continuous improvement efforts in lab procedures, develops best practices and obtains appropriate training, and ensures compliance to Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs).
• With minimal guidance, performs quality scientific experimentation to develop robust analytical methods. Implements Quality by Design (QbD) / Design of Experiment (DOE) concepts in methods development where appropriate. Makes sound scientific conclusions and decisions.
• Documents analytical testing using good documentation practices.
• Drafts analytical methods, protocols, and reports with minimal guidance, executes laboratory investigations and study protocols.
• Troubleshooting and resolve problems related to analytical methods and laboratory instrumentation.
• Collaborates with multidisciplinary teams, including product development, quality, and regulatory.
• Help train junior personnel in laboratory job functions.
• Prepares analytical data for regulatory submissions.
• Supports investigations for deviations and ensures proper corrective actions are taken.

• 5-8 years of relevant experience with a Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, or equivalent
• 1-4 years of relevant experience with a Master's Degree or PhD in Chemistry, Biochemistry, Pharmacy, or equivalent
• Must have basic knowledge and training in using a variety of laboratory instruments and techniques in the pharmaceutical industry, i.e. HPLC, wet chemistry, etc.
• Must have experience in an R&D or quality control work environment, demonstrating flexibility and adaptability to changing business needs such as changing project priorities, work assignments, etc.
• Previous experience with dissolution is preferred. Experience with modified-release drug products is also a plus.
• Strong written and verbal communication skills required.

Overview:

The individual in this role will lead development and characterization of formulations that provide abuse-deterrent/tamper-resistant properties. He/she will balance internal design effort with initiatives to identify, organize and engage in external collaborations based on current and emerging needs. Broad knowledge of small molecule formulation approaches, drug delivery, and general pharmaceutical product development is required. The successful candidate must have proven ability to meet technology development and research goals on aggressive timelines while having a record of collaboration with quality units and regulatory stakeholders. Experience in translating pre-clinical formulation work and clinical feedback into robust dosage form candidates for regulatory submission is essential, and knowledge of cGMP and other relevant regulation is required.

• Lead formulation development
• Work with external and internal team members to develop formulations with desired quality attributes
• Meet agreed upon milestones within established time and budget parameters
• Identify, manage and contribute to external formulation collaborations
• Contribute to scientific and strategy discussions to advance and enhance technology platforms and identify product candidates
• Evaluate and interpret analytical data
• Provide technical support to Manufacturing, Quality Assurance, Documentation, Regulatory Affairs, and Marketing in the introduction of new products
• Write protocols, SOP’s, detailed technical reports on studies completed and periodic reports of on-going studies
• Interact closely with clinical development group and partners in planning formulation evaluation/PK studies
• Provide support for production of clinical trial material
• Prepare chemistry, manufacturing and controls portion for IND/NDA/ANDA submissions
• Continually evaluate new technology and products
• Comply with all aspects of cGMP, Safety, DEA and Environmental legislation and with company policy

• M.S. or Ph.D. in Pharmaceutical Sciences or similar discipline with 3-10 years of experience in product development. B.S. degree in similar discipline with a minimum of 10 years of experience will also be considered.
• Hands on experience in the formulation of solid and liquid dosage forms including experience with sustained-release products
• Experience in operation of state of the art pharmaceutical equipment used for solid dosage forms
• Knowledge of oral controlled drug delivery systems preferred
• Understanding of GMP/GLP and FDA guidelines
• Ability to work independently and in a team environment
• Must be willing to be “hands on” or to train and direct junior staff as required
• Highly effective interpersonal, organizational, oral and written communication skills
• Proactive and innovative problem solving skills
• Creativity, imagination, and ability to transform ideas into patentable and marketable products and processes

Overview:

The individual in this role will conduct quality scientific analytical experimentation to support development of robust formulations.  He/she will test finished product samples.  The analyst will be trained on standard analytical chemistry techniques common to small molecule pharmaceutical development, particularly HPLC and dissolution.  The successful candidate will work effectively in team environment and work well with others.  Training on and compliance with current Good Manufacturing Practices and other relevant regulations is required

• Perform duties according to standard operating procedures in a cGMP environment
• Perform physical and analytical testing on in-process and finished product samples using HPLC, KF and dissolution equipment
• Perform assays and procedures as outlines in cUSP
• Assist in writing and updating standard operating procedures as well as reports summarizing out of specification or out of trend data.
• Document analytical testing using good documentation practices.
• Investigate with direction out of specification/ out of trend results
• Assist in troubleshooting instrument related issues with supervision
• Perform routine equipment maintenance/calibration per SOPs
• Perform other functions and tasks commonly routinely required in a quality control laboratory as required.

• Bachelor’s degree in chemistry or other science-related field required
• 0-1 years of experience in a cGMP pharmaceutical manufacturing environment
• Previous bench chemistry and HPLC experience preferred.
• Ability to prioritize and multi-task required.
• Ability to take and follow directions and work within a team environment.
• Strong written and verbal communication skills preferred

https://home.eease.adp.com/recruit/?id=14944131

Position Overview and Responsibilities: 

As the Senior Program Manager, you will partner closely with Program Leaders and cross-functional Project Team members, and bring the best practices of Program Management to Decibel Therapeutics. You will be responsible for the coordination and operational management of Decibel discovery, preclinical, and early development programs. By building, tracking, and maintaining project plans, you will ensure that all parties are aware of program activity, issues, and contingencies, and when relevant activities need to be started and completed such that program deliverables are successfully executed in accordance with program and disease area objectives, and are within budget. As the Senior Program Manager, you will prepare detailed minutes for all program team meetings and Decibel Therapeutics executive team reviews. In partnership with Executive and Program leadership, will be responsible for coordinating and/or preparing monthly reports, budgets and resource plans for the organization. With your experience, you will demonstrate the foresight to proactively identify downstream issues that may delay timelines and impede progress towards reaching goals, and will provide crisp, explicit recommendations to keep critical activities on track. As one of the key early hires for the company, you will work in close collaboration with the management team and scientists to ensure that our pre-clinical programs and technology platform are based on solid scientific foundations, accurate feasibility assessments, and grounded in realistic, corporate aligned goals.

Requirements:

• BA or MA degree with 8+ years biotech or pharmaceutical industry experience in project management within research
• Strong understanding of cross-functional early drug discovery, pre-clinical needs, and early development cross-functionally
• Fluency in the essential project management tools and techniques (e.g., MS Project Server, Excel)
• Ability to capture and present key messages derived from large amounts of program information
• Team player and strong organization and communication skills with the appropriate attention to detail (PPT presentations, writing, etc.) 

Knowledge, Skills, and Abilities:

• Ability to work with sense of urgency and commitment to meet aggressive timelines
• Ability to thrive in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient are essential
• Ability to work independently and successfully in a matrix environment, and to prioritize and manage multiple tasks simultaneously
• Ability to integrate cross-functional issues and balance competing priorities effectively
• Strong analytical and organizational skills (resources, timelines, cost/risk/benefit analysis)
• Track record for gaining the cooperation of others and brokering communication and alignment between project teams and executive governance

Syros Pharmaceuticals is an innovative drug discovery company focused on discovering and developing first-in-class medicines targeting gene control for the treatment of cancer and related conditions. Syros was founded in 2012 by leading scientists from the Whitehead Institute and the Dana Farber Cancer Institute and is supported by top venture firms and a world class Scientific Advisory Board. Combining new insights into enhancer function with information from genome-wide profiling, new targets and new chemical approaches, Syros is unlocking the process of gene control for drug discovery.

Syros Pharmaceuticals is seeking a Research Associate in Immunology to join a team of highly motivated scientists that are using recent fundamental insights into transcriptional regulation to discover novel targets for the treatment of human disease.

The candidate must have a coursework background and strong interest in Cell and Molecular Biology and Immunology. Knowledge of and interest in Immune assays (Autoimmunity) is a plus. Previous research lab experience in Academia and/or Industry is also desired. Cell culture experience is a plus.

Responsibilities:

• Design and execution of cell-based assays for multiple protein targets
• Performance of FACS analysis and co-culture experiments
• Investigation of molecular mechanisms of selected immune targets of cell growth and differentiation
• Integrated data analysis and interpretation

Requirements:

• B.S/M.S. in Biology or Cell Biology/Immunology or related discipline.
• Expertise in experimental design in Immunology, Cell Biology, and Immuno-oncology

Including:

• ELISA, FACS, and cell culture , and co-culture assays
• Gel-based approaches (Western, IP, etc.)
• MLRs, cell proliferation assays, Luminex

We seek an experienced Director/Sr. Director in regulatory science specialized in Chemistry Manufacturing and Control (CMC) for biologics. Reporting to the Vice President, Regulatory Science this person will be responsible for the development and management of the Regulatory CMC group and for providing reg‑CMC strategic leadership to support multiple gene therapy development projects both in the US and internationally, in the early and late stage of development.

This senior position will be responsible for leading the development of innovative CMC regulatory strategies and the preparation and submission of high‐quality CMC sections of INDs, CTAs, and original marketing applications (BLAs/MAAs), in close collaboration with regulatory team members, our in‐house CMC and Quality teams, contract manufacturing organizations, external experts and global health authorities. Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.

About the role:

• Development of innovative CMC regulatory strategies

• Oversee CMC‐regulatory activities and timelines; anticipate requirements for future commercial filings

• Oversee planning, preparation and submission of high‑quality CMC‐related applications globally; this will require excellent cross‐functional leadership skills as well as a good understanding of the underlying science

• Ensure that CMC‐related applications, are complete, well‐written, and meet all relevant requirements for the development of gene therapy products

• Participate in discussions with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally

• Support Quality and CMC team during GMP inspections

• Assess regulatory impact of proposed manufacturing process changes

• Lead regulatory-CMC intelligence activities

• Some travel required, approximately 15-25%

About you:

• Master’s degree in biochemistry, chemistry, biology or related pharmaceutical fields including chemical engineering required; Ph.D. degree desirable

• 10 years of relevant biopharmaceutical industry experience with at least 5 years of experience in CMC‐focused Regulatory Affairs preferably for biologics

• Recent experience with CMC‐related regulatory interactions and BLA/MAA filings

• Excellent written and oral communication and interpersonal skills.

• Strong knowledge of current Good Manufacturing Practices (GMP)

• Thorough understanding of relevant drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines

• Thrive in a fast‐paced environment

• Detail oriented; science-based reasoning skills

• Experience in the field of gene or cell therapy

• Ability to execute and follow-through to completion and documentation.

• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.

• Independently motivated, detail oriented and good problem solving ability.

• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.

• Excellent communication skills and ability to influence across multiple functions.

• Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

Foundation Medicine is seeking a talented and highly motivated Project Coordinator to manage the ctDNA assay validation and concordance study. The Project Coordinator will be primarily responsible for sample tracking and be the main internal and external contact for all sample receipt and data collection items. The position requires both the desire to work in a laboratory environment and manage projects and will work closely with Foundation Medicine’s Research and Development, Strategic Alliances, Clinical Operations, and Data Reporting and Analysis teams. The candidate will play an integral role in the successful and timely completion of ctDNA study.

• Work closely with laboratory teams to help with sample receipt and accessioning of ctDNA samples, including proper specimen handling, labeling, and preparation for processing.
• Perform data entry into existing or new systems to track samples through lab process and update team on sample related items.
• Reach out to collaborators to gather follow-up data information; responsible for pairing ctDNA sample to tissue biopsy sample.
• Ensure that sample tracking system is kept current with collaborator, subject, and material data.
• Maintain documentation on key study contacts available to address all sample related inquiries and issues.
• Work with data analysis teams and organize reporting of ctDNA result data to collaborators.
• Schedule meetings with key FMI study stakeholders and/or external collaborators to ensure study is hitting deadlines; generates team meeting minutes.
• Builds and maintains relationships with key personnel.
• Continuously looks for ways to accelerate project completion.
• Ensures timely documentation and communication of decisions and updates on timelines and deliverables

• 1+ year performing project management within the Diagnostics or Biotech industry
• Demonstrated success with management of projects
• Excellent verbal and written communication skills
• Strong attention to detail
• Prior experience (1-2 years) of having worked in a BL-2 lab setting with handling of blood specimens

Education

• Undergraduate degree in a Life Science

Apply Here

PI92239250

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Director/Senior Director, Biostatistics:

Position Summary: 

In this leadership position, the Senior Director, Biostatistics will direct a team of statisticians supporting drug development activities and decision making encompassing Phase I-IV studies. This includes guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Proven experience in strategic input into clinical development plans, and familiarity with regulatory standards and requirements.  

Duties and Responsibilities:

• Develop and lead a team of high performing Clinical Biostatisticians to meet corporate regulatory, scientific, and business objectives
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
• Guide team of biostatisticians in the design, and analysis of clinical studies using appropriate and innovative statistical methods  
• Provide oversight of statistical and strategic content in support of regulatory interactions
• Effectively coordinate statistical endeavors with outside organizations, CROs and consultants
• Identify and implement emerging new ways of doing clinical development and new methodologies
• Participate in establishment and development of department SOPs
• Oversee vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
• Maintain an active role in planning and preparation of regulatory submissions- briefing books and integrated summary documents
• Contribute to project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Operations management

Education & Experience Requirements:

• Ph.D. in Statistics or Applied Mathematics
• 12+ years of  clinical research and drug development experience
• In-depth knowledge of methodologies applied in clinical trials with focus on registration and life-cycle management
• Extensive experience of interactions with regulatory agencies- US and Non-US
• Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
• Strong communication and interpersonal skills; ability to interact with cross-functional teams
• Flexible to changing priorities, detail-oriented, works well under pressure
• Ability to communicate statistical information to non-scientists, willingness to educate internal team
• Experience in managing team of statisticians, and resource planning 

Travel Expectations:

Travel domestic and international- up to 15%

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Position Summary:  Responsible for coordination and oversight of data management activities in support of the clinical trials/programs

Duties and Responsibilities: 

• Clinical sub-team team leader: works closely with the Clinical Trial Manager and is responsible for oversight and execution of data management activities for assigned clinical studies including data timelines and key deliverables
• Preparing, validating and maintaining clinical trial databases according to ICH/GCP guidelines and current regulatory requirements. 
• Leads in database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manuals. 
• Leads in database build and UAT.
• Develops and executes data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., data review guidelines, computerized edit check programs, Data Management Plans (DMP). 
• Responsible for executing or overseeing data cleaning activities: includes generating and managing clinical trial data queries, coding specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events. 
• Tracking and reporting data management project status. 
• Assisting in data system development initiatives and database integration projects.
• Works directly with and oversees CROs and vendors for Data Management services.
• Participation in outsourcing/vendor selection for Data Management services and software.
• Tracks data status and timelines and feeds data into performance metrics reporting for assigned clinical projects.
• Provides input and participates in development of clinical study documents including protocol and monitoring plans.
• Supports CTM in coordination of receipt of all ancillary data e.g. safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock.
• Participate in SOP development, training, process mapping, and other departmental activities.

Education/Skills and Experience Requirements:

• Science background BS or healthcare degree
• Experience minimum 5+ years in a pharmaceutical/biotech, CRO setting, global/international experience a plus
• Expertise EDC and industry standards including ICH-GCP guidelines, and CDASH/CDISC
• Strong understanding of Basic, SAS, SQL and/or other clinical programming. 
• Strong understanding of application of clinical data coding classification systems, e.g.,  MedDRA, WHO-Drug. 
• Strong interpersonal, organizational, and communication  skills
• Excellent attention to detail and problem solving skills
• Ability to work effectively work in a team setting

Physical Demands and Work Environment:

●   Travel domestic and international – less than 10%

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

What’s in it for you?

In this role, you will have an opportunity to design, develop, and demonstrate manufacturing bioprocesses for microbiome therapeutics. You’ll establish yourself as a subject matter expert in upstream process development of anaerobic microbial strains commonly found in the human microbiome, with emphasis on medium development, small-scale and high-throughput cultivation systems, bioreactor cultivation, process analytical technologies, and harvest operations that may include concentration and diafiltration technologies. While becoming a technical subject matter expert, you’ll also develop yourself into a project leader, with focus on overseeing and implementing conceptual scoping, process design, equipment selection, vendor interaction, technology transfer, and process demonstration with varying degrees of responsibility. Finally, we’re looking for team members that are awesome coaches and mentors for our current technicians, engineers, and scientists, and with a real focus on building and supporting a learning organization. This is going to enable you to become an expert in becoming a leader by influence – critical to building the Seres Therapeutics family.
In the course of becoming all of the above, you’ll form really close partnerships within the bioprocess development team (analytical, formulations, and process development). You’ll also partner closely with Quality Assurance and Control, ensuring strict compliance with appropriate cGMPs. You’ll be interacting intimately with both manufacturing and discovery, and providing key input to the project teams, and when you’re ready, you’ll be a part of that product development team!

How do you know if you’re the right fit?

If you think you’re ready to build a company that is challenging some of the oldest paradigms in medicine…
“What do you mean you’re going to treat infections with more bacteria? Are you nuts?” No, we’re not nuts, but we’re a super motivated, highly talented, very integrated group of scientists and engineers developing new ways of helping patients.
…Then we want to hear from you. This means you want to have impact at Seres by participating in building out a world-class bioprocess development team, with direct influence on culture and philosophy. To be successful you will have had significant relevant industrial experience of biologics or vaccine process development or manufacturing sciences and technology, with a focus on microbial systems. You’ve managed complex projects (on-scope, on-budget, on-time), demonstrated exceptionally clear communication, and you’re very comfortable in a fast-pace, often changing and uncertain environment, but for which the mission and true North are well defined.

The other stuff

This is typically a role best suited for Ph.D. level candidates who have had direct reports in a top-notch biopharmaceutical environment. This role will report to the Senior Director of Bioprocess Development and have direct accountability for success of the CMC team as you will be a key member of the core leadership along with your peers in process, analytical, and formulations development.

Syros Pharmaceuticals is seeking experienced and dynamic medicinal chemists to join a team of scientists using recent insights into transcriptional regulation to discover and develop novel medicines targeting gene control. 

Candidates must have 5-10+ years of industrial experience in small molecule drug discovery, having demonstrated leadership and success in advancing medicinal chemistry programs across various stage gates, including delivery of novel compounds to clinical study.  Ideally the candidate has experience in medicinal chemistry projects across a variety of target classes, chemistries and project stages.  The candidate will be an outspoken and critical thinker, will blend creativity with problem-solving skills, and will weigh and take risks in order to advance discovery programs.  The candidate must exhibit exceptional communication skills as this role will include a high frequency of discussions with multiple scientific disciplines, senior management, external advisors and contract research organizations.

Responsibilities:

• Develop chemistry strategies, including activities, resources, timelines and deliverables consistent with project and corporate goals
• Prosecute medicinal chemistry programs
  • Hypothesis-driven design and synthesis of small molecule ligands

• Integrated analysis and interpretation of multi-faceted biological data sets
• Identify and provide scientific and strategic options to address programmatic liabilities

• Develop and execute synthetic sequences to deliver target molecules, with a balance of internal lab work and management of CROs
• Work collaboratively and diligently with other scientific functions, designing and executing on key experiments to drive drug programs
• Contribute to the build-out of an internal chemistry laboratory

Requirements:

• Ph.D. in Organic or Medicinal Chemistry with 5-10+ years industrial experience or MS in Organic or Medicinal Chemistry or related field with 10+ years of industrial experience in small molecule drug discovery
• Demonstrated track record of moving molecules through stage gate milestones (e.g. hits to leads, leads to development candidates)
• Ability to interpret complex data sets and design target molecules to address liabilities
• Strong desire to work in the laboratory, expediting synthesis towards key medicinal chemistry solutions or solving complex chemistry issues
• Capacity to interpret multi-factorial biological data sets (biochemical, cell based, pharmacokinetics, in-vivo) and design follow-up studies to advance programs
• Experience with state-of-the-art computational approaches, including structure-based drug design, to advance chemistry projects strongly preferred
• Proficiency in transitioning projects to late-stage optimization, defining and executing on synthetic routes to enable scale-up of key intermediates and final products
• Experience with multiple target classes and chemistries
• Desire and ability to work in a cross-functional and flexible team-oriented environment
• Strong interpersonal, verbal and written communications skills

What’s in it for you?

In this role, you will have an opportunity to work with senior staff to design and execute experiments to develop world-class bioprocesses for the manufacture of our microbiome therapeutics. You’ll be an integral member of a team breaking new ground in all aspects of upstream and downstream process development – working with human-derived commensal organisms in the areas of medium development, small-scale and high-throughput cultivation systems, fermentation, process analytical technologies, and cell harvest and purification operations. You’ll help shepherd our pipeline therapeutics candidates through the product evaluation cycle, providing samples for discovery, pre-clinical pharmacology studies, and clinical manufacturing. Your input and observations will be a valuable resource throughout our process development cycle and for the manufacturing execution of our product therapeutics.

Seres Therapeutics is a tight-knit and high-energy community of scientists and engineers with a positive culture built on interaction between functional groups. Not only will you interact closely across the bioprocess development team (analytical and formulations), but also with other CMC groups (manufacturing) to drive technology transfer. Additionally, you will collaborate with Quality Assurance and Control to ensure strict regulatory compliance, with Intellectual Property to protect and preserve our scientific advancements, and with Research and Discovery (microbiology, disease-specific leaders, and computational experts) to learn about our library of commensal strains and their impact on disease.

How do you know if you're the right fit?

Are you looking to break new ground and upend the ways diseases are managed and treated? You’re a good fit if you have an enthusiasm to use a combination of experience, literature knowledge, and elbow grease to drive towards scalable and manufacturable bioprocess solutions. You have experience with some of the project components listed above, and a willingness to learn the rest by immersion. We’re an ambitious, clinical-stage company, so it will help if you’re very comfortable in a fast-paced environment working on multiple projects with shifting priorities based on a combination of business strategy, regulatory feedback, and pre-clinical data.

The other stuff:

This is typically a role best suited for those with several years of in-house experience, a Bachelor’s or Master’s degree with majors in microbiology, biological engineering, or chemical engineering preferred. The ideal candidate will have 5+ years of industrial experience, preferably in a biopharmaceutical environment. This role will report to a Senior Engineer or Scientist in Bioprocess Development.

Computational Chemists

Syros Pharmaceuticals is seeking dynamic and experienced computational chemists to join a team of highly motivated scientists that are using recent fundamental insights into transcriptional regulation to discover and develop novel medicines targeting gene control. Syros’ computational chemists will assume primary responsibility for flexibly applying sophisticated computational methods to solve varied drug discovery projects.

We are an innovative drug discovery company founded in 2012 by leading scientists from the Whitehead Institute and the Dana Farber Cancer Institute with support from top venture firms and a world class Scientific Advisory Board. Combining new insights into enhancer function with information from genome-wide profiling, we are pursuing new targets and chemical approaches in an effort to unlock the process of gene control for drug discovery.

Responsibilities:

• Advance Syros discovery projects: Working collaboratively with project medicinal chemists and structural biologists to understand and design novel small molecule inhibitors
• Deploy state of the art computational chemistry solutions to advance discovery projects:
  • Molecular modeling of program small molecules
  • Prospective analog and focused library design
  • Structure based design
  • Pharmacophore modelling
  • Molecular Dynamics analyses
  • Drive program data mining and analysis to establish complex SAR
  • Enable and exemplify Multi-Parameter Optimization within program teams
  • Virtual Screening – assemble and maintain all available chemical libraries into a virtual screening collection to be deployed for hit ID and/or scaffold morphing
  • Target and Hit Validation: Working with Syros’ Computational and Platform Biology groups to develop algorithms, analyze and prioritize targets for further biological and/or pharmacological validation. Develop and apply sophisticated methods to determine target tractability.
  • Flexibility: work with project team scientists across a portfolio of projects to fully understand the issues and deploy the most appropriate computational approach to deliver timely, actionable solutions
  • Identify Key Collaborators, Vendors or Contractors to provide novel and/or highly complex methodologies as needed
  • Leadership: Dependent upon candidate’s leadership interest, aptitude and experience, opportunity to lead a discovery project team.

Requirements:

• Must have 5-10+ years of experience in the pharma/ biotechnology industry
• Ph.D. in Computational Chemistry
• Deep subject matter expertise in structure-based design and/or cheminformatics is essential
• Track record of advancing novel small molecules from discovery into lead optimization and through to development candidate selection as a computational chemistry project representative (or Project leader)
• Demonstrated experience in successfully selecting, negotiating and implementing software and hardware solutions. Experience in implementing and administering cloud computational access is preferred.
• Demonstrated strong written and verbal communication skills - the ability to clearly and persuasively articulate complex computational concepts and strategies to a diverse audience.
• Strong, demonstrable track record of scientific leadership excellence
• Desire and ability to work in a fast paced, cross-functional, flexible and team-oriented environment

Candidates who are enthusiastic team players that have a passion for making a difference in the discovery and development of life-saving medicines are encouraged to apply.

SeraCare partners with diagnostics researchers, IVD manufacturers and clinical laboratories to shape the future of medical diagnostics.  Our innovative portfolio includes ACCURUN® quality controls, research panels, SeraCon® processed biological materials, specialty human blood products and characterized disease state materials.  For over 20 years, SeraCare has been a leading partner to the largest global diagnostics manufacturers, providing critical tools and support that help to improve and accelerate their cutting edge product development programs. SeraCare helps bridge the gap between today’s diagnostic solutions and tomorrow’s emerging technologies for molecular diagnostics, next generation sequencing and companion diagnostics.

The Senior Manager/Director, Quality Systems oversees the administration of the Operations Quality, Quality Engineering, Supplier Quality, and Document Control functions to ensure compliance is achieved throughout the procurement, receiving, manufacturing, distribution, post market and field service areas. This position is also responsible for ensuring capable processes in manufacturing areas through proper process validations and ongoing inspection and testing in compliance with the SeraCare Quality System, ISO 9001, ISO13485, European Medical Device Directive, other applicable international regulations/requirements and the US FDA Quality System Regulation (QSR). Interacts with regulatory agencies and customers during audits for all issues related to operations, including ISO registrars and FDA representatives. 
This position works collaboratively with all departments within the organization to identify and prioritize tasks required to achieve business goals and objectives. 
This position also works hand in hand with key site leaders to establish common goals, objectives, and projects to improve, product performance, efficiency and overall cost of quality and drives improvement in customer satisfaction and financial results. 
Essential Duties & Responsibilities 

• Drive improvement of the Quality System by developing and improving procedures, identifying tools and providing training to ensure compliance requirements are being met at the manufacturing site(s).
• Identify areas requiring quality improvement and initiatives and follow through on action plans necessary for implementation
• Support Development/Operations Engineering and Manufacturing to resolve technical issues by implementing corrective and preventive actions and reporting on status, as applicable
• Provide quality metric data for areas assigned monthly
• Accomplish results working
• Participate in internal and external audits representing Quality for the areas assigned
• Drive continuous improvement efforts by facilitating, leading, and collaborating with cross functional teams
• Responsible for team building, identifying resource gaps, and working in collaboration to create personal development plans to enhance the capabilities of the department
• Develop, manage and execute Quality Plans
• Ensure that projects are completed on schedule and within budget
• Maintain compliance with Human Resource policies
• Work on special projects as they arise

Knowledge, Skills & Qualifications 

• Must be able to apply GMP principles to risk management, production and process controls, and other pertinent elements of the Quality System
• Must have knowledge of Quality Engineering discipline, including statistics; ASQ Certified Quality Engineer preferred.
• Strong Quality Auditing principles.
• Strong working knowledge of DMAIC / Six Sigma problem solving process
• Proven track record of initiating and driving continuous improvement. Team-oriented and able to lead and influence without authority. Team building and collaborative leadership skills are necessary.

Education and Experience 

• Bachelor’s degree in life sciences or chemical engineering or similar discipline
• 10+ years of experience is required; progressively assuming additional responsibility
• Managerial experience in one or more of the following: Quality, Engineering, or Manufacturing Operations
• Direct experience with medical devices and regulatory environments (i.e. QSRs, ISO9001, ISO13485, etc.) is required
• Experience with FDA inspections and successful track record with inspection outcomes is necessary

Benefits: The position is full-time and salaried with Competitive Pay, excellent benefits including medical and dental coverage, vacation and sick time, STD/LTD and a 401(k) plan.

SeraCare Life Sciences, Inc. is an Equal Opportunity Employer, M/F/D/V