partner organizations and with stakeholders from R&D through to manufacturing. The technical product lead will act as an overall technical SME for the product from R2D transition through to commercialization and will be the primary contact for product related questions.
In addition, the PTL will be accountable to drive the technical product strategy as well as year over year performance in terms of productivity and reliable manufacturing performance. The PTL will lead a matrix team to drive product strategy and coordinate all technical deliverables in the CMC Sections of INDs, NDA/MAA submissions. The PTL will also monitor product performance and be accountable to provide updates and
influence decision making by PO&T leadership via appropriate forums. This is a hybrid role that can be based in Research Triangle Park, NC or Cambridge, MA. Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.
What You'll Do Technical representative and Technical Team lead at Asset teams. Responsible to lead cross functional matrixed technical team to set, drive and deliver technical Asset goals within established timelines ASO portfolio development coordination. Ensure development deliverables - including tox batches, development and process characterization studies etc. - are planned, tracked and completed in a timely manner.
Coordinate technical Sections for IND and NDA/MAA submissions within set timelines and point of contact to coordinate responses to Information Requests from regulatory authorities.
Drive technical aspects of the integrated control strategy for ASO programs, including collaboration with Preclinical Safety and Quality to establish appropriate specifications for release and stability End to end product oversight from early development (pre-R2D) through to commercial manufacturing to ensure consistent performance and to ensure product performance oversight to drive early detection of issues before they impact quality performance or supply. Also includes coordination between Manufacturing, Quality and CMC teams to ensure smooth product transitions from development to commercial production.
Propose asset technology strategies through backssment of academic and industry trends to identify new technologies or approaches to drive product performance and reliability Drive LCM and other Yo Y improvements to drive productivity, improved COGM and manufacturing reliability. Qualifications Who You Are As the CMC Lead for antisense oligonucleotides (ASOs), you are a highly skilled and motivated professional with a deep understanding of oligonucleotide (or related compound) development and manufacturing processes.
You possess extensive experience in leading cross-functional teams to drive all Chemistry, Manufacturing, and Controls aspects of oligonucleotide drug development and commercialization. Your expertise lies in generating strategies and executing plans to ensure the successful transition of ASOs from research through to commercialization. Required Skills Bachelor's degree with at least 12 years' experience in Biopharma technical/process development. Equivalent experience equals a Master's degree and at least 10 years of experience Proven experience in leading Matrix teams Demonstrated expertise and experience in process development and commercialization of ASOs (or related products)Extensive knowledge of regulatory requirements for ASO (or similar) products Strong analytical and problem solving skillinteractioncellent communication and presentation skillinteractionperience in the preparation of Module 3 sections and prior engagement with regulatory authorities Preferred Skills Ph DAdditional Information Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team.
We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to interaction, gender identity or expression, interactionual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. PDN-9a733ba1-b361-49fa-a87d-8482f753eb7d For more details: jobs-search. org/manufacturing_cambridge-c434666/product-technical-lead-antisense-oligonucleotides-cambridge_i1959025791
of Parks, the Gardener: Performs a variety of manual work involved in planting, caring for, and maintaining gardens, shrubs, lawns, flowers, trees, and other plants. Seeds lawns and gardens, including pruning of trees and shrubs. Plants and transplants flowers.
Performs weeding, watering and fertilizing. Cares for lawns and ornamental gardens. Determines care needed by plants, trees, flowers, shrubs, and lawns; with assistance of the appropriate supervisors. Performs related manual tasks such as cutting grass, clearing snow, raking, digging, edging and pruning. Uses equipment, tools, and vehicles necessary to gardening work and snow clearing Performs other duties as required from time-to-time
including snow and other inclement weather or emergency duties. MINIMUM REQUIREMENTS: Possession of a current and valid Commercial Driver's License Class B plus a current and valid Hoisting License class 2B (backhoes and loaders) as issued by the Department of Public Safety.
Department of Transportation medical certifications may be required of applicants pursuant to the Teamsters Local 25 collective bargaining agreement. A minimum of 1 year demonstrated work experience in planting, caring and maintaining gardens, PHYSICAL DEMANDS: Lifting between 25-100 pounds, repetitive proper bending, squatting, stretching, pushing, climbing, dragging, and pulling. OTHER INFORMATION: Exposure to all
weather conditions. Work in a moderate to high noise level environment caused by sound of machinery or powered equipment being used.
Occasional odor may occur during the course of work. Required to adhere to all safety rules and regulations as well as dress code policies. Perform other related duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. REQUIRED DOCUMENTS: Please upload the below documents to complete your application. Resume PDN-9a3ccad7-dd8a-4bf2-b109-85f2da7e5b70For more details: jobs-search. org/marketing_cambridge-c434666/gardener-special-meoiia-cambridge_i1959026041
in Biogen's GMTO function. In this role, you will manage overall manufacturing responsibilities across the portfolio, technical transfer of processes and methods (both Biogen internal assets and strategic partner programs run in Biogen) into internal factories and external CDMO plants, including (in differing proportions of shared accountability with Development, depending on modality) early clinical programs, late-stage/PPQ, and commercial programs going to new sites.
Deploys GMS technical TT leads, technical product leads, process SMEs, Process Sciences labs/scientists, Materials Sciences lab/scientists, and data analytics scientists to ensure new campaign success; materials and consumables
suitability for use; supplier technical readiness; tools for campaign, batch, and materials visibility; process troubleshooting and correction; and development and implementation of lifecycle process improvements for commercial assets.
You will also ensure that new processes, materials, control technologies, and monitoring approaches and tools are manufacturing-ready in a phase-appropriate/stage-gated manner. MAIN RESPONSIBILITIES With broad accountability in driving the shared goals of GMTO and PO&T, this leader sits on the Senior Leadership Team (SLT) for GMTO and provides insight and recommendations to guide and set the strategy for the overall GMTO organization and interacts with/presents
to the PO&T SLT as needed. In this role, you must also maintain a degree of visibility to tactical considerations and issues that relate to or impact clinical and commercial processes, as well as the transfer of processes into internal factories and external plants.
You will partner collaboratively with peers and leaders in the other PO&T line functions to ensure that GMTO is ready to both receive and execute new processes/products, and to ensure that new technologies for process and plant are robust, implementable, and sustainable in a manufacturing environment. You will serve on joint steering committees for major strategic partners. As a leader of GMS, the role is highly impactful to GMTO operations and to the success of PO&T's assets: this team's work ensures successful timelines for starting and completing clinical and PPQ campaigns in high run-rate plants and CDMOs; technical support during clinical and commercial campaigns; timely investigation and correction of manufacturing process issues; and contribution to and review of key sections of regulatory filings for new assets.
Ensures that late-stage processes are ready for process validation, and owns and drives the process validation master plan, protocols, and reports. The Materials Science team ensures vendor technical readiness for raw material and consumables supply to Biogen and provide raw materials analytical characterization and monitoring to look for " unknowns" before materials are committed to GMP batches.
The site teams provide expert process support as needed for Operations, both internally and externally. Also, they provide technical management of strategic partner relationships, including tech transfer and batch/campaign/issue visibility for partners. Directs direct reports (GMS Leadership Team) to ensure success in meeting PO&T's strategic goals and Asset Team timelines and milestones.
Sets strategy and goals of GMS to align with GMTO and PO&T and responds agilely to new asset acquisition and partner opportunities as they arise. Ensures that GMS site and global line functions are working in a matrixed framework to drive the needs of internal asset timelines, strategic partner program timelines, and GMTO. Partners with leadership in Global Engineering, Manufacturing, ADPM, Quality, and Regulatory Affairs to ensure that cross-functional teams are working smoothly to deliver and maintain processes and controls that are timely, phase-appropriately ready for manufacturing, and compliant, to meet clinical and commercial Supply Chain needs.
Understands and responds to business priorities and translates into tactical objectives and work direction for the site MS teams. Includes the direct and matrixed GMS team listed above. Ensures that production schedules and Asset Program deliverables are not compromised due to tech transfer/process transfer issues, partnering with the other GMS line functions as required. Manages budget (~$22MM OPEX, ~$2.5MM CAPEX yearly), staffing, and performance management duties for GMS. Mentors direct and indirect reports on development planning and possibilities for their careers, both within GMS and across Biogen.
Ensures compliance of investigative activities across modalities within the GMS team with c Gx P regulations and maintains a high degree of regulatory compliance with FDA, EMA, and other agency guidelines and regulations to ensure solid data packages and data-integral reports for filings. Responsible for relevant CMC sections of clinical and commercial product regulatory filings. Provides technical SME support during site regulatory inspections, both from directly reporting staff at the inspection site and from the matrixed GMS line functions.
Responsible for overall process validation process monitoring and CPV to ensure process robustness and to identify process improvements inclusive and exclusive of LCM opportunities. Improvement plans to drive year over year soft and hard savings across the organization. Qualifications The ideal candidate will be an established leader in this space and will have led and motivated teams. Professional Qualifications A minimum of 15 years' experience in a biomedical/medical manufacturing environment with at least 8-10 years of senior management experience.
Education: Degree in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or closely allied discipline; Ph. D. in relevant fields is preferred. Deep technical and scientific competencies across multiple modalities. Demonstrated success in managing, motivating, and continually strengthening a large, complex, and multi-disciplinary organization. High complexity of challenges and decision-making requirements - management of a multi-line team that covers all phases of GMP operations, internally and externally, across all modalities in which Biogen works.
Demonstrated capabilities in transforming and modernizing a sizable operation by appropriately leveraging standards and technology and innovative end-to-end thinking. Ability to build, convincingly communicate and execute strategic and operational plans for a global function. Strong ability to prioritize and deploy resources across the organization rapidly to respond to changes in schedule, shifts in modality needs, and operational surprises, and at the same build business models for major areas of accountability for GMS so that the delivering team can apply standard work as much as possible for efficient use of resources.
Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy. Exceptional leadership skills, with the ability to communicate vision, set direction, as well as inspire, motivate, and mentor a cross-functional team. Ability to travel as needed both domestically and internationally Must be able to work on campus 2-3 days a week Personal Characteristics A proven ability to operate effectively in a rapidly changing environment where analytical skills and agility are equally as important; a strategic thinker who is operationally focused who can manage diverse agendas and personalities Self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and thrives in a dynamic environment as a leader influencing change and transformation Credible and savvy business person who is well networked across the industry and will be perceived as a trusted consultant and functional expert to senior management.
Must be an influential advisor; bold and courageous while having the antennae to understand cultural and political nuance Knowledgeable in leading-edge security business practices, trends, and information; aware of strategies and tactics being applied in the marketplace that are innovative Able to engender trust and respect quickly as a manager of people, with a priority on staff development.
A capability builder at both the organizational level as well as the individual level An individual of unquestioned personal and business integrity who will be viewed as trustworthy both within the company, as well as with external relations A mission-driven individual with high energy and high levels of perseverance; works towards both individual and team goals Additional Information All your information will be kept confidential according to EEO guidelines.
Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.
We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to interaction, gender identity or expression, interactionual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.
Biogen is an E-Verify Employer in the United States. PDN-9aab8b8c-2ad6-44c0-9c5f-781fc74d2ab3For more details: jobs-search. org/manufacturing_cambridge-c434666/head-of-global-manufacturing-sciences-cambridge_i1959027829
that is reflective of the community we serve. The city is also deeply committed to creating an environment in which all our employees are treated equitably and feel included. We seek to hire, develop, and advance individuals who value antiracism, diversity, equity, and inclusion (ADEI), and are committed to embedding ADEI best practices and tenets in all aspects of our work.
ABOUT THE DEPARTMENT: The Department of Human Service Programs (DHSP) creates and coordinates services that enhance the quality of life for Cambridge residents. Driven by the needs of residents, DHSP's extensive services and programs touch almost every sector in the city: from newborns to senior citizens, from school-aged
children to homeless families, from non-profit organizations to local employers. ABOUT THE ROLE: Reporting to the Aquatics Manager, Lifeguards will supervise the activities of swimmers and enforce pool safety rules at the indoor War Memorial Pool and outdoor Gold Star Pool.
They will also teach swim lessons. Group lessons are offered to surrounding summer camp and day programs and focus on Red Cross level 1,2, 3, & 4 skill building. ESSENTIAL DUTIES AND RESPONSIBILITIES: Supervises the activities of swimmers by enforcing pool safety rules and regulations. Teaches Swim lessons as needed at both the indoor War Memorial pools and our outdoor pool in the summer (WSI certification within 12
months of hire preferred. )Maintains constant surveillance of patrons in recreation facilities.
Warns swimmers of improper activities or hazards. Prevents injuries by minimizing or eliminating hazardous situations or behaviors. Able to identify swimmers in distress, perform the appropriate save and provide necessary care. Notifies appropriate personnel of any accidents, rescues, or problems that have arisen, equipment repairs needed, or facility maintenance required. Answers inquiries pertaining to use of pool and deals with patron issues in a respectful way. Works effectively with other lifeguards or staff and attends staff meetings as needed. Performs additional duties as required (i.
e. upkeep of office space, performing in service trainings). Reasonable accommodation may be made to enable qualified individuals with disabilities to perform essential job functions. MINIMUM REQUIREMENTS: Education and Experience Current American Red Cross Certificates in Lifeguarding and CPR/FPR. Must be at least 16 years old. Knowledge, Skills, and Abilities Ability to pass swim test administered by department. Ability to react calmly and effectively in emergency situations, follow instructions and communicate effectively with the public required. The City of Cambridge's workforce, like the community it serves, is diverse.
Applicants must have the ability to work and interact effectively with individuals and groups with a variety of identities, cultures, backgrounds, and ideologies. PHYSICAL REQUIREMENTS, WORKING CONDITIONS, WORK FLEXIBILITY AND ACCOMODATIONS: While performing the duties of this position, the employee is frequently required to sit, kneel, stand, stoop, communicate, reach, and manipulate objects. This position requires mobility and an ability to deliver swim lessons to swimmers of various skill levels. Duties require attentiveness to visual and audible cues for recognition and identification of swimmers in distress or in process of unsafe behaviors.
The position requires proficient swimming ability and the proper application of rescue and first-aid techniques as well as the ability to properly extract victims from the pool(s) to the deck and move equipment. Chlorinated Natatorium including lighting and heating/cooling systems. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform essential job functions. REQUIRED DOCUMENTS: Please upload the following documents to complete your application: Resume Cover Letter PDN-99206bb0-74ba-47bd-9689-97b0c3c37143For more details: jobs-search.
org/lifeguard_cambridge-c434666/lifeguard-summer-positions-cambridge_i1959025803
partners, community specialists and skilled nursing facilities. Our vision is to transform care to improve lives. Atrius Health provides high-quality, patient-centered, coordinated, cost effective care to every patient we serve. By establishing a solid foundation of shared decision making, understanding and trust with each of its patients, Atrius Health enhances their health and enriches their lives.
Atrius Health is part of Optum, a health services company focused on building the leading value-based care system in the country. If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information. SUMMARYThe LGBTQ Care
Facilitator, as a member of a LGBTQ Adult primary healthcare team, facilitates the process of care for Atrius's LGBTQ Adult Primary Care patients, coordinates an accessible plan of care and backss for clinical triggers.
They will serve as a liaison among the primary care team, specialist physicians, behavioral health team members, care management social workers, and the patient and/or patient's family. This role is scoped for 1 year, with the potential for renewal. The Care Facilitator is a critical team member in creating an exceptional patient experience. Vital to this role is forming longitudinal relationships with LGBTQ patients, regularly backssing their clinical or social needs,
and coordinating with primary care, case management, and social work teams to refer patients to community support services, aligned with their LGBTQ identity and values.
As part of forming longitudinal relationships, the facilitator is expected to maintain an understanding of the patient's identity, pronouns, preferred language and cultural beliefs and values which impact care, patient experience or recommended treatment plan. The person in this role will also provide data management of the LGBTQ patient population, and conduct patient outreach for follow-ups, referrals, and specialized care needs. The Care Facilitator populates standardized clinical and social information in the administrative areas of the care plan in the patient's medical record, and collects data, and generates reports.
Ensures clinicians are informed of assigned patients' status and may present performance metrics to larger group of clinicians. Attends required specialty meetings and participates in care improvement activities as needed to improve quality performance. These activities include, but are not limited to, a monthly patient advisory council workshop and ongoing training for the care team and front office staff. EDUCATION/LICENSES/CERTIFICATIONSHigh School diploma or equivalency certificate (e.
g. GED, Hi SET, TASC Test) from an accredited institution or governmental unit required. College degree in health care administration or psychology strongly preferred. A bachelor's degree in related field (typically in healthcare administration, psychology or healthcare related field) can at times be substituted for work experience. EXPERIENCEExperience typically acquired through three years of experience in a clinical setting. Previous training or experience work in population health management preferred. MR experience and/or aptitude to master the EMR based on other technology experience required.
Experience working with the LGBTQ community in a facilitator or coordinator capacity and/or exposure to the local LGBTQ ecosystem is preferred. SKILLSProficiency in data management, including the ability to extract data and develop spreadsheets, required. Knowledge and understanding of medical terminology required. Proficiency in Microsoft Office, especially Excel is required. Strong interpersonal and communication skills needed with the ability to interact effectively with patients and medical professionals. Ability to demonstrate a high level of cultural competence and sensitivity to patient needs and concerns.
Ability to engage patients in problem solving. Sound judgment with the ability to work and make decisions in a fast-paced environment. Computer skills that include proficiency with electronic medical records (EMR), Microsoft Office - especially Word and Excel are required. Knowledge and understanding of medical terminology. Excellent telephone skills, strong customer service and ability to build relationships with patients are required. Atrius Health is committed to a policy of non-discrimination and equal employment opportunity. All patients, employees, applicants, and other constituents of Atrius Health will be treated with respect and dignity regardless of race, national origin, gender, age, religion, disability, veteran status, marital/domestic partner status, parental status, interactionual orientation and gender identity and/or expression, or other dimensions of diversity.
BENEFITS INCLUDE: Up to 8% company retirement contribution Generous Paid Time Off 10 paid holidays Paid professional development Generous health and welfare benefit package Atrius Health is an equal opportunity/affirmative action employer and does not discriminate in recruiting, hiring, training, promoting or any other employment practices on the basis of race, color, religion, interaction, marital status, age, interactionual orientation, gender identity, national origin, military service or application for military service, veteran or disability status.
Applicants have rights under Federal Employment Laws: Family and Medical Leave Act (FMLA); Equal Employment Opportunity (EEO); and Employee Polygraph Protection Act (EPPA). VEVRAA Federal Contractor Request Priority Protected Veteran & Disabled Referrals for all of our locations within the state PDN-9a8d4eb8-7e88-4b27-b0f7-97cd04cab336For more details: jobs-search.
org/technology_newton-c434659/lgbtq-care-facilitator-newton_i1959027105
