Astellas Pharma jobs in Alameda, CA

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Purpose and Scope:** The Bioanalytics team is seeking a candidate to support the daily operations of the Histology laboratory at our West Coast Innovation Center (South San Francisco, CA). **Essential Job Responsibilities:** + Process animal tissues for fixed and frozen samples, ensuring high quality preservation. + Embed, section, and mount tissue for paraffin and frozen samples. + Perform chromogenic, immunofluorescent (IF), and H&E staining using manual and automated platforms (Leica Bond Rx, HistoCore Spectra, etc.). + Develop and optimize single and multiplex staining protocols. + Conduct quality control and maintain detailed records of procedures and results. + Maintain sample, reagent, and equipment inventories. + Collaborate with team members, providing technical expertise and troubleshooting support. **Required Qualifications** + BS in Biology or related field (MS preferred) with ≥3 years of histology experience. + Hands-on experience with trimming, processing, embedding, microtomy/cryotomy, special staining, and IHC (manual and automated). + Strong communication and teamwork skills, with a proactive approach to delivering high quality work **Preferred Qualifications** + Experience with Olympus VS200 and HALO imaging quantification software. + Familiarity with Leica Bond, Leica Pegasus, and HistoCore Arcadia platforms. + Experience with in-situ hybridization (ISH) and quantification techniques. + Experience in ophthalmology-related research and/or gene therapy studies. **Salary Range** **:** $79,800 - $125,400(Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program _All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._ \#LI-TR1 Category Integrative Science Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities: Represents the assigned products to health care professionals in assigned sales territory. Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers. Develop and execute comprehensive business plans. Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices). Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient treatment. Analyze customer needs and interests, territory performance, program outcomes, and business trends; develop and execute business plans that optimize the commercial potential of our products. Maintain expert understanding of the relevant disease state(s), assigned Daiichi Sankyo brands, and competitor products. Completes all assigned training. Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts. Communicates on a regular basis with District Manager, internal and co-promote peers and discuss issues and opportunities. Builds relationships with Daiichi Sankyo customer base and key opinion leaders. Communicates products approved indications, features and benefits in both individual and group settings. Meet all administrative expectations and standards, including budgets, reporting, and communication. Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. Submits completed reports on-time and communicates matters that are relevant to the marketplace to the District Manager. Maintains all equipment and territorial records in the prescribed manner. Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. Adhere to compliance and operating principles and expectations. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): Bachelor's Degree required Experience Qualifications: 4 or More Years of sales/marketing experience in the pharmaceutical or medical industry required 4 or More Years of oncology therapeutic experience strongly preferred 1 or More Years additional therapeutic experience in diverse roles - training, marketing, market access preferred Oncology product launch experience preferred Copromotion experience a plus Strong verbal and written communications skills Proficiency in MS Word, Excel, PowerPoint and Outlook Additional Qualifications: Must be able to travel approximately 40% to 60% Must have a valid driver's license with a driving record that meets company Compensation and seniority level/title based on experience and qualifications Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $139,440.00 - $209,160.00 Download Our Benefits Summary PDF

This position offers a base salary typically between (115,000) and (181,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The EHS Senior Specialist - Fremont supports the site Environmental Health and Safety programs to maintain compliance with applicable State and Federal regulations, corporate requirements, and other legal requirements, and to help protect the health and safety of BIPI employees, to protect the environment, and to minimize risks to the company. The EHS Senior Specialist - Fremont aids the EHS Managers and will also solely manage a limited number of EHS programs. The position also plays a key role in assisting internal customers with their EHS needs. Duties & Responsibilities Assists the EHS Managers with program compliance activities to ensure adherence to regulatory requirements. Programs may include Field Force safety, chemical, biological and radiation safety, industrial hygiene, environmental programs, include general safety programs such as Lock out Tag out, Hot Work, powered industrial trucks, confined space, fall protection, machine guarding, robotic system safety, and others. Helps to maintain written programs in a compliant state, conducts training, aids and conducts routine follow-up audits of programs periodically. Maintains all training programs and revise as necessary. Manages a select number of site EHS&S programs in compliance with applicable Local, State and Federal regulations, Corporate requirements, and in order to help protect the health and safety of employees, to protect the environment, and to minimize risks to the company. Supports the overall company in meeting the Greener and sustainability initiatives. Requirements B.S. in Science or related field from an accredited institution; MS/MBA preferred. Requires at least five (5) years' experience in EHS or related field, including at least three (3) years' experience with the relevant technical subject matter as detailed in this job profile. Certifications strongly preferred or ability to obtained certification within six months of assignment: Certified Safety Professional, Certified Industrial Hygienist, Certified Professional Ergonomist, and/or Certified Hazardous Materials Manager. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

Boehringer Ingelheim is currently seeking a talented and innovative Intern to join our MSAT Drug Product department located at our Fremont, California facility. As an Intern, you will be part of a team supporting Drug Product manufacturing to develop technical solutions to aseptic manufacturing and packaging problems, As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees **This position offers an hourly pay typically between (20.00) and (33.00). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.** **Duties & Responsibilities** + Modify the scale-down table top stopper insertion machine to mimic the commercial stopper insertion process + Using the modified stopper insertion machine, develop a procedure for assessing the impact of process variables to manufacturing visual defects. + Work with the manufacturing team to transfer processes and solutions. + Summarize study results in a report. **Requirements** + Must be a current undergraduate, graduate or advanced degree student in good academic standing + Student must be enrolled at an accredited college or university for the duration of the internship/co-op + Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred + Major or minor in related field of internship/co-op + Undergraduate students must have completed at least 12 credit hours at current college or university + Graduate and advanced degree students must have completed at least 9 credit hours at current college or university **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** + Hands on mechanical skills, able to operate lab scale equipment from operational manuals + Experience with plastic parts design and 3D printing is a plus + Excellent writing and communication skills All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: Northern CA, NV and UT Responsibilities: Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: Presenting disease state and Daiichi Sankyo product specific data to HCPs Responding to unsolicited requests for medical information Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards Gathering customer insights regarding DSI and competitor products to help inform medical and commercial decision-making Enhanced professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders Develops positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships Develops the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies Completes administrative duties, including monthly expense reporting and field activity reporting Represents the Medical Science Liaison function by participating in DSI meetings, functions, events Additional duties and responsibilities are based on position level/title, and may include but are not limited to: Provides innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives. Ability to anticipate trends and capitalize on opportunities Lead special projects/initiatives. Assist in the development of team members Represent FMA leadership at DSI meetings, functions and events Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): PharmD, MD, PhD, NP or PA in a health sciences-related field or an equivalent combination of education and experience required Experience Qualifications: MSL/Sr. MSL 1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Principal MSL/Associate Director MSL 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Additional Qualifications: Must have a valid driver's license with a driving record that meets company requirements Ability to travel up to 60% Compensation and seniority level/title based on experience and qualifications. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $150,800.00 - $226,200.00 Download Our Benefits Summary PDF

Boehringer Ingelheim is currently seeking a talented and innovative Intern to join our Global Facilities Engineering, Facilities Engineering group located at our Fremont, California facility. As an Intern, you will employ your understanding of drug substance manufacturing of biopharmaceuticals, in collaboration with other necessary technical support functions associated with critical GMP utility equipment, to provide real-time process monitoring, troubleshooting, and continuous improvement for clinical and commercial scale GMP production. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **This position offers a base salary typically between (20.00) and (33.00). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.** **Duties & Responsibilities** _Duties will include:_ + _Collaborate with other team members in cross-functional_ _teams to improve processes and equipment in the GMP-manufacturing facility as it relates to utility equipment_ + _Standardize training, generate SOPs and provide work instructions to assist with onboarding of new employees and equipment within the GFE Engineering department_ + _Use data management & visualization software for process modeling and/or equipment troubleshooting purposes (e.g., PI Vision, Excel w/ macros, JMP, Minitab, MS Office suite)_ + _Generate process maps, process flow diagrams, and functional presentations for key processes to identify areas of potential improvements and opportunities for efficiency gains_ _Develop system playbook AI agents to assist the system owners with management of their respective_ **Requirements** + Must be a current undergraduate, graduate or advanced degree student in good academic standing. + Student must be enrolled at an accredited college or university for the duration of the **internship/co-op** . + Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred. + Major or minor in related field of **internship/co-op** . + Undergraduate students must have completed at least 12 credit hours at current college or university. + Graduate and advanced degree students must have completed at least 9 credit hours at current college or university. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** + _BS or MS candidate in Chemical or Mechanical Engineering, or related discipline (i.e. Electrical Engineering, Project Management, Construction Management)_ + _Fundamental grasp of fluid dynamics, mass transfer, and thermodynamic concepts_ + _Proficiency with Microsoft Office_ All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Purpose and Scope:** The Disease Mechanism Research team is seeking an exceptional scientific leader versed in state-of-the art methods in oncology research. The ideal candidate should demonstrate deep understanding of cancer biology and provide scientific direction for pre-clinical research in Astellas' Cancer Biology team. The successful candidate will lead a diverse team of scientists to build a deeper understanding of cancer biology in focused cancer indications and advance the Astellas oncology pipeline. **Essential Job Responsibilities:** + Expert knowledge of tumor biology, including cancer cell intrinsic and extrinsic mechanisms leading to disease progression and maintenance + Provide extensive expertise in cancer biology, including model and assay development to support preclinical drug development + Establish key in vitro and ex vivo immuno-oncology assays and models suitable for therapeutic evaluation and mechanistic investigation across the Astellas portfolio + Mentor and support a team of junior researchers to address mechanisms of action and resistance to cancer therapies + Contribute to program development through broad expertise in oncogenic signaling pathways + Manage multiple projects simultaneously and act as a project lead to effectively collaborate cross-functionally with colleagues across the Astellas organization + Effectively communicate with team members to efficiently conduct experiments, articulate experimental details and results with other members of the Astellas research organization, and present research findings and recommendations to senior leadership **Qualifications Required:** + PhD and post-doctoral training in cancer biology, cancer immunotherapy or a closely related fields with a minimum of 7+ years postdoctoral experience in an academic or industry setting + Experience and strong interest in cancer therapy and/or immuno-oncology research + Demonstrated expertise in solid tumor biology and tumor model development + Proven ability to drive innovative research strategies and deliver results + Recognized leadership in mentoring talent, establishing best practices, and ensuring experimental rigor + Excellent verbal, written, and interpersonal communication skills are essential + Strong work ethic with a dedicated mindset of proactively identifying and productively filling gaps **Preferred:** + Understanding of novel modalities in cancer therapeutics including but not limited to targeted protein degradation, ADC and bispecific T cell engager platforms + Knowledge of methodologies employed in tumor metabolism research + Experience in multicellular in vitro models **Working Environment:** + This position is based in South San Francisco (West Coast Innovation Center) and will require on-site work. **Salary Range** : $140,000 - $220,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-TR1 Category Cancer Biology Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** About Astellas Gene Therapies Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: ****************************** The Role As part of the Data Systems & Controls team, the Senior Labs Systems and Application Engineer will deliver IT support for our pilot plant and research laboratory systems, working onsite at our South San Francisco, CA location. This role requires advanced technical skills and a strong focus on customer service and systems ownership. The Senior Labs Systems and Application Engineer must be a team player that understands the importance of collaboration and can drive projects and the resolution of issues to completion with minimal supervision and effective utilization of vendor and contract resources. Some travel may be required. Responsibilities Leads projects to deliver or enhance systems and applications through researching technologies, developing solutions or roadmaps, and drafting design and configurations to meet the needs of stakeholder group requirements Responsible for systems ownership, administration, and deployment including routine preventative maintenance, change control, procedure development, and technical assistance to operations Investigates and troubleshoots technical problems of increasing complexity, utilizing system documentation, and addresses system outages/issues impacting operations by identifying, prioritizing, and resolving issues Monitors and verifies acceptable performance and accessibility of newly deployed IT solutions and performs investigations and deliver corrective actions, as required Supports the Digital Analytical Technologies team in the implementation of network and infrastructure changes impacting the lab and production systems and applications Ensure compliance with lab instrument backup & archiving disaster recovery requirements. Work schedule includes ‘out of normal' work hours for IT support, maintenance, or other activities as required Organizational Context: This position is a technical and team leadership position reporting to the Associate Director, Data Systems & Controls within the Astellas Gene Therapies Research & Technical Operations Division.

Boehringer Ingelheim is currently seeking a talented and innovative Intern to join our MSAT Process Validation department located at our Fremont facility. As a Co-op student, you will generate validation documents (protocols/reports) and support execution of validation studies (lifetime, mixing validation, etc.). In addition, you will also support Continued Process Verification (CPV) program for various products at Fremont Biopharma facility including setup parameters for process monitoring in CPV software, update Control Strategy Summary and support protocol/report generation . As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees Duties & Responsibilities Responsible for validation documents (protocols/reports) and support execution of validation studies (lifetime, mixing validation, etc.) Support client and site audit activities as required Responsible for setup trending parameters in CPV software, printing trending reports, identifying trend signals and facilitate expert meetings Requirements Must be a current undergraduate, graduate or advanced degree student in good academic standing Student must be enrolled at a college or university for the duration of the internship Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred Major or minor in related field of internship Undergraduate students must have completed at least 12 credit hours at current college or university Graduate and Advanced Degree students must have completed at least 9 credit hours at current college or university Desired Experience, Skills and Abilities: Knowledge in Process Validation and CPV is preferred. Experience with planning and generating validation protocols and reports. Excellent technical writing and verbal communication skills. Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision. Compensation Data This position offers a base salary typically between (20.00) and (33.00). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.

**Position Overview:** We are seeking a highly skilled and experienced Director of Engineering, Manufacturing to lead our engineering team. The ideal candidate will have a strong background in medical devices, including both hardware and consumables expertise. Knowledge of ultrasonic therapy and/or PZT is a plus. This role requires a visionary leader who can drive innovation, ensure regulatory compliance, and oversee the successful execution of engineering projects from concept to commercialization. **Key Responsibilities:** + **Leadership & Management:** + Lead and mentor a team of engineers, fostering a culture of innovation and excellence. + Oversee the hiring, training, and development of engineering staff. + Conduct performance evaluations and provide constructive feedback. + **Project Management:** + Plan, coordinate, and supervise engineering projects within the organization. + Ensure projects are completed on time, within budget, and meet quality standards. + Collaborate with cross-functional teams, including R&D, regulatory, and manufacturing, to align engineering efforts with company objectives. + **Technical Expertise:** + Provide technical guidance and support in the development of ultrasonic therapy devices for renal denervation. + Stay abreast of the latest advancements in medical device technology and integrate new innovations into product development. + **Regulatory Compliance:** + Ensure all engineering activities comply with FDA regulations and ISO 13485 standards. + Prepare and manage documentation for regulatory submissions and audits. + **Strategic Planning:** + Develop and implement engineering strategies that align with the company's long-term goals. + Manage budgets, resource allocation, and timelines for engineering projects. + **Quality Assurance:** + Establish and maintain engineering policies, standards, and procedures. + Ensure adherence to safety and environmental regulations. **Qualifications:** + Bachelor's or Master's degree in Engineering, Biomedical Engineering, or a related field. + Minimum of 10 years of experience in medical device development, with at least 5 years in a leadership role. + Proven track record of successful project management and product development in the medical device industry. + In-depth knowledge of ultrasonic therapy and renal denervation technologies. + Strong understanding of FDA regulations and ISO 13485 standards. + Excellent leadership, communication, and interpersonal skills. + Ability to work collaboratively in a fast-paced, dynamic environment. **Benefits:** + Competitive salary and performance-based bonuses. + Comprehensive health, dental, and vision insurance. + Retirement savings plan with company match. + Opportunities for professional development and career advancement. **Salary Range:** $221,695- $240,000 **(Annual Base Salary)** **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Band Level 5 #LI-Remote The Associate Director, Access & Reimbursement, NPS (Novartis Patient Support) Cardiovascular, San Jose, CA is a remote & field-based role that covers the following, but not limited to: Fresno, Salinas, Stockton, Tracy, Clovis, San Mateo, Palo Alto & San Jose, CA. Associate must reside within territory, or within a reasonable daily commuting distance of 60 miles from territory border. The Associate Director, Access & Reimbursement (ADAR) is a field-based role that proactively provides in person (or virtual as needed) education to defined accounts within their assigned geographies on a wide range of access and reimbursement topics and needs (see below) in support of aligned product(s) strategy. ADARs primarily focus on accounts with increased process and workflow complexity, typically including centralized and decentralized systems of care, integrated delivery networks, academic medical institutions, large multi-provider specialty practices, and alternate sites of care. ADARs will serve as the patient access and reimbursement lead in business-to-business conversations with account executives. The ADAR role is responsible for managing the pull-through of access and reimbursement strategy and downstream operations within their aligned accounts. ADARs are expected to have deep expertise in communicating requirements and addressing barriers associated with local payer policy coverage, multi-channel acquisition pathways, billing and coding education (as needed), claims processing, reimbursement, and integration of manufacturer support programs into a range of account workflows. ADAR will continually need to demonstrate a keen ability to problem solve and manage multiple projects. ADARs partner closely with other Novartis Pharmaceuticals Corporation (NPC) field associates, including Customer Engagement (Sales) and Market Access, representing NPC with the highest integrity in accordance with NPC Values and Behaviors. ADARs will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third party affiliates). Job Description Key Responsibilities: Interact with large, complex accounts to support patient access within their aligned therapeutic area product(s), proactively provide face-to-face education on programs to providers and staff in order to support integration of those products into office processes and workflows. Address customer questions for issues related to NPC policies on therapeutic area products ordering, payment, inventorying, and product returns & replacement in offices. Work with key members of therapeutic area offices (e.g., executives, providers, administrators, billing and coding staff, claims departments, revenue cycle managers) in order to appropriately support patient access to products. Ability to analyze problems and offer solutions. Understand specifics and support questions associated with patient reimbursement and provide support on reimbursement issues with third party payers at the provider-level. Analyze account reimbursement issues (as needed). Identifies trends at a local, regional and national level and partner with purpose internally and externally to support patient access to Novartis medicines Supports pull through on local coverage decisions to enable meaningful patient access within the system. Proactively communicate policy changes or issues that could potentially affect other departments. Accountable for informing customers on NVS-sponsored patient support programs to help enable patients starting and staying on therapy (i.e., Co-pay). Maintain expertise in regional and local access landscape, anticipating changes in the healthcare landscape, and act as their aligned therapeutic area product(s) reimbursement expert (as needed). Interface with Patient Support Center (hub) and Access & Reimbursement Managers on important matters related to patient case management, including tracking cases, issue resolution, reimbursement support, and appropriate office staff education. Collaborate with aligned cross-functional associates within NPC (see above) to share insights on customer needs and barriers for their aligned therapeutic area product(s) related to access and reimbursement. Maintain a deep understanding of NPC policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. Handle Patient Identifiable Information (PII) appropriately (understand and ensure compliance with HIPAA and other privacy laws and regulations and internal Company compliance guidelines). Responsible for identifying and reporting adverse events via the established Novartis systems as per applicable processes. Buy and Bill Specific Assess access situation within the assigned geography and develop appropriate Plan of Action (POA). Communicate POA to appropriate personnel. Responsible for educating HCPs using approved materials regarding acquisition pathways for Novartis products. Educate on buy-and-bill end-to-end processes, workflows, and facility pull-through in complex accounts, including scenarios of centralized and decentralized acquisition, and use of alternative channels such as white bagging, clear bagging, brown bagging, and alternate site of care for administration. Educates relevant stakeholders on logistics related to ordering, payment, inventory, and product returns & replacement. Analyze reimbursement issues, anticipating changes in the healthcare landscape, and act as the designated reimbursement expert for offices and field teams. Accountable for engagement with non-prescribers in regards to Novartis medicines, for example pharmacy, system leadership, financial counselors, office administrators, revenue cycle managers, etc. What You'll Bring to the Role: Education: Bachelor's Degree required. Business and/or biological science education preferred. Advanced degree preferred. Essential Requirements: 5+ Years of experience in pharmaceuticals / biotech industry focused in Patient Services, Market Access, Sales, and/or account management. With 2 of those years being in a Patient Services practice support role for a specialty product(s). Experience working with highly complex practices and/or health systems to establish access and acquisition pathways. Strategic account management experience using a proactive approach to anticipate access hurdles impacting accounts and patient access. Deep expertise and experience integrating manufacturer-sponsored patient support programs. Experience with specialty products acquired through Specialty Pharmacy networks Knowledge of reimbursement pathways (specialty pharmacy, buy-and-bill, retail) Possess a strong understanding of Commercial payers, Medicare plans and state Medicaid in geographic region. Must live within assigned territory. Ability to travel and cover geography, at least 50% travel required, based on geography and territory / targeting make up. Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. Desirable Requirements Experience leading and delivering presentations to C-level account executives. Strong ability to work cross functionally with such functions as Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management and applicable third-party affiliates. Expertise in therapeutic area practice dynamics and common reimbursement and product program support-related needs. Strong capabilities in the areas of customer focus, collaboration, business acumen, communication, and presentation skills. This position requires significant use of a company provided vehicle and maintaining good driving record This is a field-based customer engaging position Control business expenses related to field activities (i.e. travel, customer meetings) and provide timely expense reports to manager. Compensation Summary: The salary for this position is expected to range between $160,300 and $297,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to ********************************** For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to ************************ call **************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. *************************************************************************************** Salary Range $160,300.00 - $297,700.00 Skills Desired Access And Reimbursement Strategy, Agility, Analytical Skill, Analytical Thinking, Cross-Functional Collaboration, Customer-Centric Mindset, Employee Development, Finance, Go-To-Market Strategy, Healthcare Sector Understanding, Health Economics, Health Policy, Health Technology Assessment (HTA), Innovation, Inspirational Leadership, Market Access Strategy, Negotiation Skills, People Management, Process Management, Public Affairs, Real World Evidence (RWE), Regulatory Compliance, Risk Management, Value Propositions, Waterfall Model

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ******************** . **The Role** As part of the Research Compliance team, the Validation Engineer plans and executes risk-based qualification and computerized systems validation activities in cell and gene therapy research environments and advances data integrity improvement programs for systems and equipment platforms. The role manages contractor resources, partners with cross functional research and enterprise supportive functions and drives deliverables to completion with minimal supervision. **Responsibilities:** **CSV and Qualification Lifecycle** + Plan and execute risk-based CSV for research computerized systems and instrument-connected software, including URS, functional and design specifications, configuration records, risk assessments, traceability matrices, IQ, OQ, and validation summary reports. + Qualify non-computerized equipment (e.g., freezers, refrigerators, incubators, TCUs, chromatography columns) using a fit-for-purpose, risk-based approach, including URS, risk assessment, calibration/verification, temperature/CO₂ mapping where applicable, functional and alarm checks, acceptance criteria, maintenance plans, periodic requalification, and documented change control. + Validate data migrations, interfaces, and integrations between lab and enterprise systems. + Maintain lifecycle controls, including change control, deviation handling, CAPA linkage, and validated state documentation. + Coordinate and document vendor assessments, service qualifications, and supplier deliverables used as validation inputs. + Ensure validated-state documentation, vendor service records, and calibration certificates are current and audit-ready. + Initiate, assess, execute, and close change controls related to equipment and systems tracked in BMRAM. + Ensure changes are documented, assessed for impact, and properly linked to validation deliverables. **Data Integrity Program** + Lead Data Integrity Risk Assessments for new and existing systems, define mitigations, track actions to closure, and maintain a cross-site DI risk register. + Establish and run periodic reviews, including audit trail review strategy and execution, backup and restore verification, security and access recertification, time synchronization checks, data retention and archival verification, and disaster recovery elements aligned to ALCOA+ plus principles. + Define data flows and lifecycle maps for key applications and studies to ensure traceable, attributable, legible, contemporaneous, original, and accurate records. + Align validation and DI deliverables to enable product characterization work packages that support regulatory submissions. + Prepare transfer packets that demonstrate fitness for intended use and continuity of controls for tech transfer to downstream GxP organizations. **Lab and equipment platforms** + Plan, execute, and periodically review controls for platforms such as LIMS, ELN, CMMS, EMS, data systems and related lab or enterprise applications used by CGT Research. + Partner with IS and DigitalX on account and role design, backup and recovery, business continuity, and incident response linkages for these platforms. **Procedures, Templates, and Training** + Author and maintain SOPs, work instructions, validation plan templates, DIRA tools, periodic review checklists, and report templates. + Deliver role-appropriate training and coach scientists and engineers on validation and data integrity practices, including good documentation practices. **Contractor and Vendor Management** + Define scopes of work, guide tasking, review deliverables, and ensure on-time, right-first-time outputs from contractors and suppliers. + Oversight of local contractors or vendors providing equipment qualification **Issue Management, Metrics, and Audit Support** + Lead or support investigations related to validation or data integrity gaps, assess impact to studies and submissions, and drive effective CAPAs. + Document root cause, corrective and preventive actions, and ensure timely closure with supporting evidence. + Maintain dashboards for CSV status, DIRA actions, and periodic review health, and present program status in reviews. + Support internal audits and GLP inspections, prepare evidence, and complete commitments. **Required Qualifications** + BS in Engineering, Information Systems, Computer Science, Life Sciences. + 8+ years of Computerized Systems Validation experience with hands-on authorship and execution of URS, specifications, risk assessments, IQ, OQ, UAT, traceability, and summary reports. + In lieu of BS degree, Associates Degree in Engineering, Info Systems, Computer Science, Life Sciences, with 10+ years of industry experience. + Demonstrated experience running DIRAs and periodic reviews, including audit trail review, access recertification, backup and restore verification, and change control linkages. + Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GLP expectations for computerized systems, and research best practices for submission-supporting data. + Excellent technical writing and documentation skills with the ability to produce clear, well-structured protocols and reports quickly. + Strong collaboration and project management skills across multi-site environments, including influencing without direct authority. + Models Astellas values, operates with transparency, and builds trust. **Preferred Qualifications** + Experience in gene therapy, biologics, or advanced therapy research organizations and GLP laboratories. + Familiarity with lab instrumentation connectivity, interface testing, and integration validation between lab and enterprise systems. + Prior responsibility for contractor oversight and multi-workstream validation delivery. + Experience preparing validation and data integrity evidence for audits or inspections. **Working Conditions:** + Hybrid office and lab setting with routine interaction with computerized systems and occasional time in labs and equipment rooms. Locations could be in South San Francisco, CA, Westborough, MA, and Seattle, WA with travel up to 10 percent. **Salary Range** : $107,100-$168,300 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program _All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._ \#LI-TR1 Category Facilities, Engineering and Logistics Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

This position offers a base salary typically between (115,000) and (181,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. To manage BIFI Environmental Health and Safety compliance programs in accordance with all applicable State and Federal regulations, Corporate requirements, and other legal requirements in order to help protect the health and safety of BIFI employees, to protect the environment, and to minimize risks to the company. Assist internal customers with their EHS needs and actively cultivate a safety and sustainability culture. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees. **Duties & Responsibilities** + Manage and continuously improve BIFI Health and Safety Programs in adherence to all Local, State, Federal and Company requirements. Health and Safety Programs managed by this position may include, but are not limited to: Industrial Hygiene, Chemical Safety, Process Safety, Ergonomics, Hazard Communication, Biosafety, PPE and other General Safety Programs including but not limited to Hot Work, Control of Hazardous Energy, Confined Space, OSHA Recordkeeping, and others. This position may serve as the Biological Safety Officer and may manage Emergency Response organizations at the site including the Emergency Evacuation Team. + Manage and continuously improve BIFI Environmental Programs in adherence to all Local, State, Federal and Company requirements. Environmental Programs managed by this position may include, but are not limited to: Air Emissions /Refrigeration Management, Wastewater Management, Protection of Surface and Groundwater, Waste Management, Environmental Remediation and Community Right to Know Reporting. + Manage and implement programs to foster a culture of safety and environmental stewardship within the various business units. Duties may include outreach activities, messaging, leading committees, and working with Senior Management to drive the BE SAFE and BE GREEN culture. + Develop, implement, and manage the EHS Management Systems for the BIFI site. Develop and implement continuous improvement concepts to better the site´s safety and environmental performance. + Business Partner EHS Program + Working with assigned Business Partners to act as focal point for resolution of their EHS concerns and issues, to communicate matters between EHS and the business partner, and to support their business partners as needed. + Miscellaneous EHS Issues as required, including but not limited to: + Participating on emergency response teams such as Emergency Evacuation teams. + Responding to incidents + Lead and participate in inspections and audits + Other tasks as required **Requirements** + Bachelors degree from an accredited institution in Science, Engineering and/or Biopharmaceuticals is required; Masters degree from an accredited institution is preferred. + Requires at least eight to ten (8-10) years´ experience in EHS at an operational facility, including at least five (5) years´ experience with the relevant technical subject matter as detailed in this job profile. + Must have significant experience managing and implementing EHS programs at operational sites on a tactical level. + Must have significant experience with the relevant technical subject matter as detailed in this job profile. + Requires four to six (4-6) years of experience leading projects. + Ability to work independently while maintaining communication with all team members. + Requires teamwork, leadership, and influencing skills with a strong focus on customer service. + Excellent communication skills, both written and verbal, are required. + Must possess strong interpersonal skills, and must offer innovative and creative solutions to customer problems. + Requires broad knowledge in EHS regulations and in the development and implementation of EHS management systems. + Requires the understanding of business interruption and crisis management risks and corresponding control strategies. + An in-depth knowledge of regulatory and legal requirements for all managed programs is required. + Occasionally will be required to work in a physically demanding environment, including conducting field work and participating in emergency response activities. + Must have the ability to lift 35 lbs. + Position may require periodic off-shift work in order to meet the needs of internal customers. + Occasional travel is required. **Desired Skills, Experience and Abilities** + Certifications preferred: Certified Safety Professional, Certified Industrial Hygienist, Certified Hazardous Materials Manager, or other similar and relevant certification. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The incumbent is responsible for providing Oncology therapeutic area (TA) disease state and product education and training to internal and external customers. This may include: prescribing and non-prescribing healthcare stakeholders, patients, care partners, consumers, community organizations, and advocacy partners. Works closely with all functions of the Patient Excellence unit, especially with Access Solutions and Hub partners, to enhance the overall customer and patient experience. May engage with marketplace stakeholders prior to, at the time of launch and after product approval. Will also support the design and development of Oncology educational resources, including disease state and management tools, healthcare provider resources, patient, care partner, community advocates, and consumer education materials and product programming. Demonstrates expert knowledge of Oncology disease state, treatment guidelines, product, supporting HCP's, Advanced Practice Providers and support staff. May identify and collaborate with local, regional, and national professional societies and organizations to enhance collaborative partnerships and may serve as an educational resource to promote disease awareness and advocacy. The incumbent may also provide disease state and product education, including regular clinical and resource updates to Specialty Pharmacy partners as well as Hub personnel. Duties & Responsibilities Increase disease state and product knowledge to a variety of Oncology marketplace stakeholders, which may include patients, HCPs (both prescribing and non-prescribing healthcare stakeholders), Advanced Practice Clinicians, the multi-disciplinary clinical team, extended support staff and community organizations. Plays a critical role in the support of marketplace stakeholders by educating on the complexities of treatment and potential for adverse events. Customer engagements may occur prior to, during and post product launch. Possessing expert knowledge, he/she may support the design of tools and resources that enhance clinical management of Oncology patients, as appropriate. The incumbent serves as an integrated educational resource for multidisciplinary support staff team members, and as a result, optimizes the delivery of holistic patient support in both academic and community settings. Through education, the incumbent will support safe and responsible utilization of therapy as prescribed by the healthcare team. Collaborates with and provides support for the entire assigned Region, which may consist of multiple cross-functional partners and may require coverage of multiple states. Serves as conduit of information supporting internal and external partners within clinics, hospitals, accounts, and in the local community, across the Region. Identifies, supports, and communicates educational and potential business opportunities for related TA product and shares intelligence with TA stakeholders, where appropriate. Supports the attainment of TA business and educational goals. Executes on patient, care partner, HCP, clinic staff and consumer focused support initiatives through collaborative relationships with local, regional and national professional associations and patient advocacy organizations. May serve as an ongoing source of continuing education and support for internal partners and external customers. They may provide assistance to Boehringer Oncology training leads, marketing partners and leadership in designing, developing and conducting appropriate product and marketplace training. May assist in the identification, design, development, and delivery of Oncology clinical educational programming, inclusive of slide kits, workbooks, and electronic media, and supports the review and approval process. Provides key insights and is a leader in the development and facilitation of educational resources on Oncology disease state and Boehringer products. Performs all company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and company policy and procedures. When violations are noted, they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community Requirements Bachelor's degree required in Nursing or equivalent health care discipline such as Pharmacy. Graduate degree, such as NP or PA degree is a plus. Active clinical license required. A minimum of 3 or more years of successful combined clinical experience and/or pharmaceutical sales, clinical and/or community educator, or medical affairs experience (primary care, specialty care, institutional). Background & experience in Oncology preferred. A minimum of 2 years experience in therapeutic area is required. Excellent communications, objective setting, and influencing skills Ability to travel in the US including overnight travel, approximately 50% (or more), depending on geography. Valid Driver's License and acceptable driving record Proficiency in Excel, Word, Outlook, and other relevant applications Success operating within a matrixed setting and rapidly changing environment Business acumen, Analytical skills, Learning and Adaptability Demonstrated experience interpreting clinical data. To be considered for this position, candidates must reside within the territory of the position. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Compensation Data: This position offers a base salary typically between $115,000 and $181,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. #LI-DG1

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** About Astellas Gene Therapies Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: ****************************** The Role As part of the Data Systems & Controls team, the Senior Labs Systems and Application Engineer will deliver IT support for our pilot plant and research laboratory systems, working onsite at our South San Francisco, CA location. This role requires advanced technical skills and a strong focus on customer service and systems ownership. The Senior Labs Systems and Application Engineer must be a team player that understands the importance of collaboration and can drive projects and the resolution of issues to completion with minimal supervision and effective utilization of vendor and contract resources. Some travel may be required. Responsibilities * Leads projects to deliver or enhance systems and applications through researching technologies, developing solutions or roadmaps, and drafting design and configurations to meet the needs of stakeholder group requirements * Responsible for systems ownership, administration, and deployment including routine preventative maintenance, change control, procedure development, and technical assistance to operations * Investigates and troubleshoots technical problems of increasing complexity, utilizing system documentation, and addresses system outages/issues impacting operations by identifying, prioritizing, and resolving issues * Monitors and verifies acceptable performance and accessibility of newly deployed IT solutions and performs investigations and deliver corrective actions, as required * Supports the Digital Analytical Technologies team in the implementation of network and infrastructure changes impacting the lab and production systems and applications * Ensure compliance with lab instrument backup & archiving disaster recovery requirements. * Work schedule includes 'out of normal' work hours for IT support, maintenance, or other activities as required Organizational Context: This position is a technical and team leadership position reporting to the Associate Director, Data Systems & Controls within the Astellas Gene Therapies Research & Technical Operations Division.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description About the Role The Data Platform team builds and maintains the foundation that powers analytics, ML, and data-driven products. As part of Platform Engineering, our mission is to enable other teams to move faster, safer, and with greater reliability by delivering scalable, observable, and compliant data systems. We're seeking a Manager, Data Platform with strong technical expertise and 2-4 years of leadership experience. You'll own the evolution of the data ecosystem from ingestion and transformation pipelines to data modeling and event-driven systems, ensuring performance and stability at scale. You will mentor engineers while staying hands-on with architecture and implementation. Who You Are You're a systems-minded leader who blends architectural vision with hands-on execution. You build for scale, reliability, and simplicity. Enabling teams across the organization to deliver trusted, high-quality data with confidence and speed. Qualifications Responsibilities Lead and grow a team of data and software platform engineers, fostering technical excellence, ownership, and collaboration. Define and execute the data platform roadmap, covering ingestion, transformation, orchestration, and data access. Design, implement, and maintain ETL/ELT pipelines and data models that support analytics, ML, and operational workloads. Architect and evolve event-driven data systems using Kafka to enable scalable, decoupled pipelines. Maintain and optimize core data tooling such as Snowflake, dbt, Airflow, and Fivetran. Ensure system reliability, observability, and performance across development, staging, and production environments. Partner with domain and product engineering teams to define and enforce data contracts, governance, and quality standards. Manage AWS-based infrastructure (MWAA, S3, RDS/Postgres, MSK, Glue, Lambda, ECS/EKS) using Terraform. Collaborate with Platform and Security Engineering on CI/CD, monitoring, and compliance practices. Champion automation, scalability, and cost efficiency within the platform. Qualifications Bachelor's Degree required 8-10 years total experience in data, software, and platform engineering roles. 2-4 years of experience leading or managing technical teams. Proficiency in Python and TypeScript for data pipeline and backend service development. Expertise in PostgreSQL, including schema design, query optimization, and replication. Deep understanding of data modeling, ETL/ELT frameworks, and event-driven architecture. Hands-on experience with Kafka, Terraform, and AWS data services. Proven success operating and scaling production data systems with high reliability and observability. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************

**Sr. R** **esearch Associate** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Purpose and Scope:** The Sr. Research Associate will support the GT Engineering team and assist in developing and executing screening assays for the evaluation of AAV vector products. **Essential Job Responsibilities:** + Perform routine cell culture work, including thawing, maintaining, expanding, cryopreserving immortalized and primary cell lines + Execute cell-based assays to test AAV vector candidates using routine procedures (AAV transduction, transfection, titer measurements, and cell differentiation) + Perform DNA, RNA, and protein isolation from mammalian cells + Analyze gene and protein expression through the application of a variety of techniques (RT-PCR, qPCR, digital PCR, western blot, immunofluorescence, and ELISA) + Collect, process, and evaluate data; Accurately document assay results and analyze data through the maintenance of an updated electronic laboratory notebook, prepare study reports, and communicate results and research progress in lab meetings as needed + Participate in sample management activities such as receiving, processing, storage, and shipping pre-clinical samples + Collaborate with other teams to acquire and aliquot vector lots, document characterization of vectors (vg titer, capsid titer, alkaline gel results) + Collaborate in laboratory management activities such as receiving, tracking, storage, and maintenance of laboratory reagent stock + Perform routine and advanced NGS library preparation workflows (bulk RNA-seq, amplicon DNA-seq, and Oxford Nanopore sequencing, etc.), including RNA/DNA extraction, library construction, and barcoding, with strong bench accuracy and consistency. + Conduct comprehensive QC and documentation for NGS library prep, including quantification and fragment analysis, while identifying issues, troubleshooting with guidance, and ensuring high-quality data generation. + Additional duties as assigned **Qualifications** **Required** : + BS degree in Molecular Biology, Biology, Life Sciences, or a related discipline with 4+ years of experience or a MS with 2+ years of experience in molecular and cell biology techniques. + Proven hands-on experience with sterile technique for handling and growing mammalian cell lines, including maintenance, cell characterization and differentiation, expansion, and banking + Demonstrated experience with routine molecular biology techniques (DNA/RNA/protein isolation, cDNA synthesis, RT-PCR, qPCR, digital PCR, western blot, and immunofluorescence) + Solid practical experience in NGS library preparation and QC across multiple sequencing modalities, with the ability to follow SOPs, maintain data quality, and operate common QC instruments (Bioanalyzer/Tapestation, Qubit, PCR). + Ability to work both independently and in a team-oriented environment to meet project goals and timelines + Strong written, verbal communication and presentation skills **Preferred:** + Experience working with viruses, especially Adeno-Associated Virus (AAV) + Experience working in biotech and pharma + Experience working with a multinational team + Experience of iPS cells or any stem cells culture **Working Environment:** + This position will be located at West Coast Innovation Center in our South San Francisco in the US and will require on-site work. **Salary Range:** $79,800 - $125,400 (NOTE: Final salary could be more or less, based on experience) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Referral bonus program \#LI-TR1 Category GT Engineering Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose: The Area Business Lead (Sales Director) is responsible for providing the leadership necessary to achieve Area level sales goals. This includes sales, sales strategy, resource allocation, and talent development. Today, the Ophthalmic team is focused on maximizing the patient impact and commercial value of IZERVAY. IZERVAY launched in September 2023 and is a complement C5 inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). IZERVAY is a Priority Brand for Astellas and has blockbuster potential. The GA market is a dynamic and rapidly evolving new category of treatment where IZERVAY is one of two options available for treatment. The Area Business Lead is responsible for leading and managing Regional Business Leaders and providing consistent and uniform direction regarding execution of sales and marketing strategies and tactics for Astellas' US products and services. Additional responsibilities include recruiting and development of field force personnel within the geography, including appropriate assessment of performance. This role has oversight and provides direction to optimally allocate key resources and inspire industry leading customer engagement across regional geographies. The ABL is accountable to maintain effective communication and relationships with key external and internal customers and accounts. Essential Job Responsibilities: Demonstrate strong, clear leadership through consistent communication and direction, and assume direct responsibility for achieving sales goals for an assigned therapeutic franchise and geography. Foster a culture of high engagement and accountability by building trust, setting clear expectations, providing coaching and development of managers. Set expectations and high standards of performance for each team member. Accurately assess the team's performance, identify and maximize talents, provide growth and development opportunities, and appropriately allocate rewards/recognition within the Sales Area. Guide and support national/area/regional business strategic plans. Track sales trends and analyze performance to ensure the area meets established goals. Develop and oversee the area's budget, allocating resources effectively. Drive sales effectiveness through execution of marketing and promotional strategies that cater to the special needs of selling in Ophthalmology (specifically) Retina environment. Ensure a high level of collaboration with matrix partners to maximize joint efforts as well as adherence to compliance standards. Work closely with Market Access to establish pull-through programs and take advantage of patient services and favorable Managed Health Care opportunities; ensure excellent coverage and customer service for key accounts in the Sales Area; and assist in ensuring adequate positioning of Astellas' products on key purchasing group's formularies in the nation. Monitor industry trends and competitor activity to guide strategic decision-making. Guide and support sales areas to recruit, train, retain and develop diverse talent to strengthen team capabilities and ensure sustainable performance. Manage and understand trends and human resource needs related to recruitment, performance management, selection, and development. Support and lead development and training initiatives across the region. Represents Astellas' Values and Behaviors by adhering to compliance policies and procedures, while promoting a culture of ethics and integrity. Ensure each Manager and Representative within each region understands, accepts, and adheres to the policies and procedures. Represent sales and collaborate across the brand while building impactful field and marketing strategies ultimately deploying and delivering within area and as needed to national team. Partner and strategize with leadership on executive exchange planning and engagements with priority accounts and/or c-suite and retina community advocates. Carry out additional responsibilities as assigned. Quantitative Dimensions: Responsible for overseeing and leading a sales area inclusive of Regional Business Leaders and Business Specialists. Direct management of Regional Business Leaders (Sales Managers). Directly responsible for providing the leadership and direction for Sales Area to achieve at least 100% goal attainment. High level of skill in developing and maintaining relationships and interacting with internal cross-functional Astellas departments and fostering a cohesive and impactful matrix team to deliver industry leading customer experience and engagement. Engaging external customers, including Key Opinion Leaders and key stakeholders including ECPs and C-Suite within accounts, to better align customer needs to the Astellas organization. Exhibit the leadership qualities and competencies essential for success in a senior leadership role. Organizational Context: Reports into the Ophthalmic Head of Sales. Leads area of regional business leaders and sales representatives.

Incubation & Acceleration Lead, Discovery, Tumor Immunity Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: To enhance our ability to serve cancer patients, deeper understanding of cancer biology in the context of diseases such as GI/GU cancers is crucial. The Incubation & Acceleration Lead, Discovery, Tumor Immunity, will report to the Head, Discovery, Tumor Immunity, and will involve nurturing ideas from internal and external sources, including academic and biotech companies in Bay Area, into drug discovery programs. With no set reporting lines, the position will liaise closely with South San Francisco based biologists, act as a hub to effectively connect small ideation teams, identify promising seeds, and manage incubation research effort to create drug discovery projects (DC) while promoting collaboration with chemistry and biologics functions. The lead will oversee three or more incubation research projects simultaneously. Essential Job Responsibilities: Strategic Leadership As a leadership member of the Tumor Immunity biology team, be responsible for developing research strategies and ideation directions, ensuring alignment with the overarching strategy of Cancer Biology. Develop a plan for accessing external seeds in collaboration with the CI&PRM team in Oncology Research and Business Development. Scientific Leadership & Oversight Identify the next area of biology to address, considering the linkage between disease pathology and biology. Work with I&A Leads and biologists to provide scientific insights for cancer biology incubation research strategies. Commit to create 1 or more DC program a year from the incubation research portfolio. Team Leadership & Management Foster a collaborative, transparent, and creative team environment that drives innovation and invention. Manage team priorities, resources, and investments in alignment with Oncology Research overall strategy and objectives.