CMC jobs near me - 110 jobs

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. The Role: The Senior Director, Drug Product will report to the Executive Director (Device Engineering and Drug Product) and will be responsible for leading formulation and manufacturing process development, technical transfer and clinical/commercial manufacturing for drug product processes. This position will work closely with drug delivery/device development to ensure the integrated development and manufacturing for combination product is in place. This position must work collaboratively with the various functional areas, including manufacturing operations, process and device development, analytical development, packing labeling, distribution, quality, regulatory and clinical operations, both internally and at CDMO/CMO companies. This role will be a key contributor within the CMC organization at Immunovant. The successful candidate will be a confident specialist with a proven track record in managing and leading drug product manufacturing for subcutaneous administration in the biotech and/or pharma industry. Key Responsibilities: Lead the formulation development, process development, and manufacturing strategies in the design and implementation of stable formulations of monoclonal antibodies for subcutaneous administration via pre-filled syringe and vials; Provide oversight of ongoing drug product production for clinical and commercial processes, ensuring supply continuity. Provide technical and scientific direction to CMOs and external laboratories to ensure project deadlines and performance standards are met; Lead the development/optimization of scalable, efficient, and cost-effective formulation efforts; Responsible for technical leadership in issue resolution with CMO partners, including design of experiments and interpretation of results; Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions. Oversee the development of technical transfer protocols and supervise the transfer of drug product manufacturing processes into cGMP drug product manufacturing facilities. Perform due diligence as needed on potential partners for fit synergies with the current portfolio. Provide oversight to combination product related activities and documentation Review analytical and clinical data to make scientific conclusions. Maintain current knowledge of regulatory environment, specifically requirements for CMC sections of clinical registration submissions Create and review technical documents, reports, and presentations for cross functional teams. Manage SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices. Qualifications: PhD with 6+ years of experience, Masters with 10+ years of experience, or Bachelors with 12+ year of experience in pharmaceutical sciences, biochemistry or another relevant field; Relevant biopharmaceutical industry experience with experience in drug product manufacturing of biologics (monoclonal antibodies preferred) for subcutaneous administration; Depth of experience in formulation and drug product process development of biologics delivered subcutaneously; Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining a positive working relationship; Proven leadership in management of CMO production; Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals; Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results; Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills; Ability to think outside of the box and challenge the status quo; Natural entrepreneurial spirit with unrelenting dedication to delivering results; Desire to work in a fast-paced, innovative environment; Natural collaborator who enjoys working on a cross-functional team Work Environment: The position will be remote; Dynamic, interactive, fast-paced, and entrepreneurial environment; Domestic or international travel required (10-20%) Salary range for posting$260,000-$275,000 USD Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

The primary function of the Quality Program Manager is responsible for providing day to day management of the quality improvement program. Responsible for coordinating activities of quality department staff, suggesting process changes, measuring data, and completing QA activities to achieve organization goals for quality measures for programs like UDS, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, CMC, and individual insurance plan contracts. Reports to: Director of Quality and Clinical Systems Supervises: Yes Dress Requirement: Business Casual Work Schedule: Monday through Friday during standard business hours Times are subject to change due to business necessity Exempt Essential Job Duties and Responsibilities Work with supervisor and members of clinical leadership to develop, implement, monitor, and measure plans to improve processes and quality outcomes. Work with supervisor, clinical leadership, data analytics team, and external data vendor Unity PHM to analyze data, clean data, and perform quality assurance activities. In collaboration with supervisor, Chief Medical Officer, and others, the position is responsible for carrying out system-wide quality programs. Assists with developing, planning, and implementing policies and procedures. Works closely with supervisors, clinical teams, and non-clinical teams for quality improvement efforts. Assists with designing processes for quality improvement purposes. Plays a key role in maximizing revenue from value-based care, pay-for-performance, and risk adjustment contracts. Ensure compliances with program requirements. Examples include individual insurance plan contracts, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, and CMC programs. Focuses on better healthcare value and quality, including the improvement of clinical outcomes, patient experience, patient safety, costs, revenue, productivity, efficiency, employee and physician satisfaction, and process reliability. Leads or participates in meetings related to quality improvement. Coordinate, manage and report UDS measures and other data related to clinical quality. Manages performance improvement projects to assure milestones and key performance indicators are met within defined parameters. Documents the results of projects, and submits other documentation as requested. Develop and motivate department staff. Interview, monitor time and attendance, and manage performance of subordinates. Report on clinical quality measures internally and externally. Provide updates to internal and external stakeholders on progress in quality initiatives. Support data collection and reporting related to grants. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice. Qualifications Education: Bachelor's degree in a related field required. Examples include nursing, healthcare administration, public health, or similar. Certifications such as CPHQ and Lean Six Sigma are beneficial, but not required. Experience: At least four years of experience in the healthcare field, quality, data analytics, and/or management strongly preferred. Master's level education and appropriate background may substitute for some experience. Knowledge of clinical operations including the functions of the front and back-office utilization information systems is preferred. Previous experience working in an outpatient clinic is preferred. Knowledge/Abilities: Excellent communication skills, both written and verbal, are required. Strong organization and time management skills are required. Ability to work independently and demonstrate initiative is required. Proficiency with Microsoft Office is required. Displays cheerful demeanor and makes positive comments when on duty. Works cooperatively with other staff members. Displays sensitivity in a multi-cultural environment. General understanding of the medical billing process is preferred. Equipment Operated : Telephone Computer Printer Fax machine Copier Other office equipment as assigned Other office and medical equipment as assigned Facility Environment : Heart of Ohio Family Health operates in multiple locations, in Columbus, OH. All facilities have a medical office environment with front-desk reception area, separate patient examination rooms, nursing stations, pharmacy stock room, business offices, hallways and private toilet facilities. All facilities are ADA compliant. The patient examination rooms and office area is: kept at a normal working temperature sanitized daily maintains standard office environment furniture with adjustable chairs maintains standard office equipment; i.e., computer, copier, fax machine, etc. at a normal working height Physical Demands and Requirements : these may be modified to accurately perform the essential functions of the position: Mobility = ability to easily move without assistance Bending = occasional bending from the waist and knees Reaching = occasional reaching no higher than normal arm stretch Lifting/Carry = ability to lift and carry a normal stack of documents and/or files Pushing/Pulling = ability to push or pull a normal office environment Dexterity = ability to handle and/or grasp, use a keyboard, calculator, and other office equipment accurately and quickly Hearing = ability to accurately hear and react to the normal tone of a person's voice Visual = ability to safely and accurately see and react to factors and objects in a normal setting Speaking = ability to pronounce words clearly to be understood by another individual

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more ************************* and follow us on X, LinkedIn and Facebook. Role Summary: Dyne Therapeutics seeks a strategic and execution-oriented Executive Director, Corporate Development to lead external growth initiatives. Reporting to the Chief Business Officer (CBO), this role focuses on identifying and executing partnership and alliance opportunities aligned with Dyne's neuromuscular focus and expansion of the FORCE platform into new therapeutic areas. The Executive Director, Corporate Development works closely with the CBO, Chief Innovation Officer, CSO, CFO, IR team, and other executives to drive strategic assessments and investor messaging. The role can be remote with travel to Waltham, MA. Key Responsibilities Business Development Execution: Support and drive business development efforts including preparing pitch decks, engaging with counterparties, supporting due diligence, and negotiations. Lead term-sheet development and negotiation in collaboration with CBO, Legal and Finance. Coordinate cross-functional diligence efforts across scientific, clinical, CMC, commercial, and IP domains. Manage external advisors, data rooms, and timelines to ensure efficient transaction execution. Strategic Planning: Define strategy and support indication assessments for Dyne's initiatives to expand the reach of its FORCE platform beyond neuromuscular disease. Build market maps and identify strategic whitespace opportunities aligned with Dyne's platform capabilities. Conduct competitive intelligence and landscape analysis to inform prioritization. Develop scenario models and strategic frameworks to evaluate new therapeutic areas and partnership opportunities. Investor Messaging: Support messaging for key investor meetings by conducting deep analysis of the competitive landscape and Dyne's position within it. Lead end-to-end execution of partnership and alliance transactions, including diligence, valuation, and negotiation. Maintain a prioritized pipeline of external opportunities aligned with Dyne's strategy. Collaborate cross-functionally to integrate scientific, clinical, and commercial insights into deal assessments. Develop board-ready investment cases and strategic recommendations. Represent Dyne externally with potential partners, investors, and at industry events. Qualifications 12+ years of experience in biotech/pharma corporate development, business development, strategy, or related fields. BA/BS required; MBA or advanced degree in life sciences (PhD/MD/PharmD) preferred. Proven track record of executing partnerships, alliances, and strategic transactions. Strong scientific literacy and ability to collaborate with R&D and innovation teams. Excellent communication skills and experience preparing investor-facing materials. Timeliness and effectiveness of partnership execution. Impact of strategic assessments on corporate direction. Quality and clarity of investor messaging and materials. MA Pay Range$241,000-$295,000 USD The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. This is a 3-month, 20 hrs/week, remote contract opportunity. Regulatory CMC Consultant Therapeutic Area: Infectious Disease Draft Submissions Support CMC Responsibilities Lead project initiatives and integrations 8+ years of Reg. CMC experience preferred #LI-EB3 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary Job Description Summary The CMC team within Alira Health Boston LLC advises and assists biotechnology companies to manufacture therapeutic biologics for clinical testing. The CMC team offers services in cell line, process and formulation development, quality, regulatory, project management and toxicology. It seeks an experienced individual to serve as a technical leader and senior consultant in process development and biomanufacturing. This is a leadership role to help guide and manage the CMC group, working in partnership with the Senior Vice President. Essential Duties and Responsibilities Responsibilities will include both client advisory and management, with a distribution of roughly 50% time for each. Client Advisory Serve on interdisciplinary client project teams to represent process development and manufacturing. Responsibility may include serving as the technical lead for one or more of these teams. Collaborate with colleagues in the CMC group to develop strategies and workflows for bioprocessing including cell line development, process development, and manufacturing. Lead identification and selection of CRO and CDMO partners for development and manufacture of drug substance and drug product through identification of potential partners, preparation of requests for proposal, review of proposals, and creation of detailed itemized proposal comparison. Manage CRO and CDMO relationships on behalf of clients to ensure successful and timely completion of project activities and milestones. Compile, analyze and report results to the client in a clear and concise fashion. Perform due diligence on assets being considered for acquisition by clients. Conduct market assessments and portfolio reviews for CDMOs and technology companies. Lead internal meetings, providing client and technology updates to the group Draft CMC sections of regulatory submissions (IND/IMPD or other). Responsible for assisting in the creation of CMC documents for IND filings to meet Global Quality standards and applicable regulatory requirements. Recognize risk and propose contingency plans. Collaborate with quality and regulatory colleagues and may interact with regulatory agencies including, but not limited to FDA, EMA, Health Canada. Participate in investigations of manufactured product to assure appropriateness and completeness of required documentation. Management Manage consulting groups to ensure that they have resources and guidance needed to staff project teams and execute client projects successfully Manage consulting staff to build competence and skills and to motivate a high level of performance Understand and monitor business performance metrics to help to achieve financial goals Support the Vice President of CMC in sourcing of potential new clients and in representing CMC to them. Participate in new client introductions to understand their priorities, and help in the creation of project scope and budget to meet the client's needs. Education/Qualifications BS/MS/PhD in molecular and cell biology, biochemistry or biochemical engineering combined with 10+ years' experience in CMC related biologics development and manufacturing roles, including demonstrated competence in a leadership role. Specific, in-depth expertise in a technical discipline; focus on manufacturing strategy and operations; knowledge of biologic manufacturing expression systems including both mammalian and microbial strains. Experience managing CRO/CDMO relationships, ideally including running vendor selection processes and contact/scope negotiations. Good understanding of FDA, EU, and ICH cGMP guidelines and industry best practice, with demonstrated ability to apply these to drug substance and drug product operations. Experience in, or at least an understanding of key elements for, successful consulting Good manager of people Sound judgment, analytical, problem-solving and decision-making skills. Ability to handle multiple assignments and changing priorities along with fluctuations in workload. Demonstrated planning, project management, negotiation, facilitation and presentation skills. Visible contributions via record of publications and conference presentations in field of biologics development Ability to work both independently and collaboratively in a team structure. Uses a team-oriented approach to project management and problem resolution. Holds self and others accountable in achieving collective goals. Excellent verbal and written communication skills, including the ability to generate reports and regulatory documents. Proficiency with Microsoft Word, Excel and PowerPoint required. Compensation package will include salary, bonus, 401k, health benefits and equity in the company. Alira Health Boston LLC is a privately held company and an equal opportunity employer. Languages Education Contract Type Regular

THIS POSTING WILL BE OPEN UNTIL FILLED Application cut-off dates are weekly, every Tuesday With supervisor approval, incumbents may be eligible for intermittent remote work; however, they must physically reside within the Sacramento region or have the ability to regularly report to a City of Sacramento physical worksite with little notice. IDEAL CANDIDATE STATEMENT This position calls for a candidate who is committed to public service, continual learning, and excellence in civic administration. The ideal professional will be curious, resourceful, and comfortable conducting research to inform sound recommendations and apply best practices to evolving municipal operations. They will communicate with confidence, clarity, and professionalism, exercising political acumen and strong analytical skills to navigate sensitive issues and provide balanced, well-reasoned advice. The successful candidate will demonstrate exceptional attention to detail, the ability to remain calm, flexible, and composed under pressure, and a deep understanding of good governance, open meeting requirements, and public transparency. They will be thoroughly familiar with the Ralph M. Brown Act and adept in all aspects of governmental meeting management, including agenda coordination, legislative process oversight, and public record integrity. This individual will thrive in a highly collaborative environment, working effectively with elected officials, executive leadership, staff, and community members to build trust and ensure the highest standards of legislative and administrative support. Experience as a supervisor who leads with integrity, mentorship, and accountability is essential. A Certified Municipal Clerk (CMC) designation is highly desirable, and experience with Granicus/Legistar is a valued asset. The ideal candidate will be an expert user of Microsoft Word and Adobe Acrobat, producing polished, accurate, and professional materials that reflect the City's commitment to excellence. This role requires frequent evening and after-hours work in support of City Council, committee, and community meetings. Under general direction the Program Specialist plans, directs, and supervises all of the activities of a major department or Citywide program or project with moderate visibility and impact; conducts studies and makes recommendations; monitors program compliance; represents the department in contacts with media, internal and external agencies, and organizations. DISTINGUISHING CHARACTERISTICS This advanced journey level class in the professional series is populated with multiple incumbents. The Program Specialist is distinguished from the next lower class of Program Analyst in that the Program Specialist manages multiple programs or moderately visible programs with greater department or Citywide impact. This class is distinguished from the next higher classification of Program Manager in that the Manager is responsible for administration and management of programs and projects with high visibility and substantial Citywide impact. This class is distinguished from the class of Administrative Officer in that the latter is responsible for all internal administrative functions for a department. SUPERVISION RECEIVED AND EXERCISED General direction is provided by a department or division head. Some assignments require responsibility for direct or indirect supervision of lower level professional, technical, and clerical personnel. Some positions function as internal consultants and require coordination among multiple divisions in a department. * Plans, coordinates, and administers, a project or program with department or Citywide impact; supervises, trains and evaluates the work of professional, technical and clerical staff. * Confers with department heads, division managers, members of professional staff, and other officials concerning the administrative needs and requirements related to the program or project; represents the program in contacts with news media, business and civic organizations, other City departments, and various outside public and private agencies. * Interprets new policies, procedures, and regulations, and develops new or amended programs or projects as need dictates, monitors program objectives to assure compliance with State and administrative regulations and program guidelines. * Conducts studies and surveys, performs research and analysis and prepares recommendations for department management; monitors and evaluates program effectiveness and outcomes; creates and implements program policies and procedures; develops guidelines, forms and related documents. * Reviews grant opportunities; compiles and analyzes information for preparation of grants, contracts and agreements; negotiates terms; implements, monitors and prepares reports on conduct and performance of grants. * Identifies program, project or system enhancements; selects and coordinates installation of new and revised programs and systems. * Provides exceptional customer service to those contacted in the course of work. * Other related duties may also be performed; not all duties listed are necessarily performed by each individual holding this classification. Knowledge of: * Principles and practices of public administration and governmental finance, budgeting, and accounting. * Procurement methods. * Research techniques, methods and procedures. * Methods and practices of modern office management. * Principles and practices of program management and administration. * Technical report writing. * Methods of analysis. * Principles and practices of supervision. Skill in: * Managing multiple tasks and deadlines. * Customer service, including dealing with people under stress, and problem solving. * Use of computers, computer applications, and software. Ability to: * Effectively plan, develop, and implement a comprehensive program with a broad scope and high degree of complexity. * Supervise and direct professional, technical, and clerical staff. * Analyze fiscal problems and make sound policy and procedural recommendations. * Make effective presentations to public officials, committees, and outside agencies. * Establish and maintain effective working relationships with employees and the general public. * Prepare technical and analytic reports. * Communicate effectively, orally and in writing. * Make program or project changes based on analysis of results, new legislation, or departmental changes. * Meet multiple deadlines. EXPERIENCE AND EDUCATION Experience: Four years of progressively responsible professional-level administrative experience. * AND- Education: A Bachelor's Degree from an accredited four-year college or university with major coursework in business or public administration or a closely related field. Note: It is highly desirable the required years of professional-level experience be attained in a governmental jurisdiction. Substitution: Additional qualifying experience may substitute for the required education on a year for year basis. PROOF OF EDUCATION Should education be used to qualify for this position, then proof of education such as, but not limited to, university/college transcripts and degrees should be submitted with your application and will be required at the time of appointment. Unofficial documents and/or copies are acceptable. An applicant with a college degree obtained outside the United States must have education records evaluated by a credentials evaluation service. Evaluation of education records will be due at time of appointment. SPECIAL QUALIFICATIONS Driver License: Possession of a valid California Class C Driver's License is required at the time of appointment. For positions where ability to drive is not an essential function, the employee must be able to arrange reliable and timely transportation through private or public transportation for attendance at off-site meetings, events, and trainings. Please note, the City of Sacramento's preferred method of communication with applicants is via e-mail. As such, please ensure you verify the e-mail address on your application, and check your e-mail frequently, including your spam and junk folders. All e-mail notifications can also be accessed through the governmentjobs.com applicant inbox. 1. Application: (Pass/Fail) - All applicants must complete and submit online a City of Sacramento employment application for further consideration by the next posted cut-off date; * Employment applications must be submitted online; paper applications will not be accepted. * Employment applications will be considered incomplete and will be disqualified: * If applicants do not list current and past job-related experience in the duties area of the "Work Experience" section. Note: Qualifying experience is based on full-time experience (40 hours per week). Qualifying experience is calculated to the full-time equivalent (pro-rated if less than 40 hours/week). * If "see resume" is noted in the "Work Experience" section; a resume will not substitute for the information required in the "Work Experience" section. * Position/job titles will not be considered in determining eligibility for meeting the minimum qualifications for this position. * Proof of education such as, but not limited to, university/college transcripts and degrees should be submitted online with your application. Proof of education will be required at time of appointment. 2. Supplemental Questionnaire: (Pass/Fail) - In addition to the City of Sacramento employment application, all applicants must complete and submit online responses to the supplemental questionnaire to the City of Sacramento Employment Office as part of the application process; * Responses to the supplemental questionnaire must be submitted online; paper questionnaire will not be accepted. * Incomplete supplemental questionnaire will not pass the review process; omitted information cannot be considered or assumed. * A resume will not substitute for the information required in the supplemental questionnaire. * Possession of the minimum qualifications is not necessarily a guarantee for further advancement in the selection process. 3. Screening Committee: (Pass/Fail) - All applications received will be forwarded to the hiring department for review until the position is filled. The hiring department will select the most competitive applications for further consideration. Human Resources will only evaluate employment applications for the minimum qualifications, as stated on the job announcement, for applications selected by the hiring department. 4. Interview Process: Human Resources will forward applications to the hiring department. Those determined to be the most qualified candidates will be invited to participate in an interview process. 5. Conditional Hire: Upon receipt of a conditional offer, the selected candidate must complete and pass Live Scan/fingerprinting. If applicable, candidates may also need to pass a pre-employment medical exam, controlled substance and/or alcohol test, and possess any required licensure or certification prior to receiving a start date from the Department. Failure to meet these prerequisites will be grounds for withdrawal of your conditional offer of employment. QUESTIONS: For questions concerning this job announcement and the application process: * Please visit **************************************************** for a comprehensive, step-by-step guide to the application process. * For technical support between 6 AM - 5 PM PT, contact Live Application Support at ************. * Visit the City of Sacramento Human Resources Department website at *********************************************** * Send an email to *******************************; or * Call the Human Resources Department at **************

COMPANY BACKGROUND Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis). We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others. Summary We are seeking an experienced and detail-oriented contract specialist to assist with preparation, review, negotiation and management of various types of contracts across their entire lifecycle. The contract specialist will collaborate with various departments, including legal and finance, to ensure that contracts align with organizational goals. The ideal candidate will have a strong legal collaboration background, with the ability to review redlines and manage contracts in a fast-paced environment. The position reports to the Senior Director of Business Operations. Prior experience in the biotechnology or pharmaceutical industry is preferred, and the ability to assist with additional projects is a highly desired trait. Key Responsibilities Manage contract requests within the contract management system to ensure timely and complete review, approval and contract execution. Prepare Confidential Disclosure Agreements (CDAs), Consulting Agreements, and Master Service Agreements (MSAs) using approved contract templates. Review Statements of Work to ensure compliance with company policies and requirements. Ensure timely execution of contracts and assist with lifecycle management (including extension of contracts prior to expiration). Handle contract amendments, extensions, and terminations as needed. Maintain contract records, monitor deadlines, and track renewals and amendments. Maintain and update contract database. Work closely with various departments, including clinical operations, CMC, legal and finance, to facilitate resolution of contractual issues and provide guidance on contract-related matters. Other responsibilities as assigned in order to meet company needs. Qualifications Minimum 4 years of contract experience, including knowledge of contract principles and procedures. Excellent communication skills (both verbal and written) and interpersonal skills are required. Self-motivated, well-organized and detail-oriented with the flexibility and ability to prioritize and handle multiple tasks in a fast-paced environment. Works well independently as well as in a team environment. Proficient in Microsoft Office applications. Demonstrates collaborative communication and problem-solving spirit. Willingness to do what needs to be done in a dynamic environment. Educational Requirements BA or BS degree required. Compensation Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas. Compensation range :$91,000 - $117,000 Special Advisory Akero will not conduct interviews via text message or messaging platforms. Please be vigilant in checking that the communication is, in fact, coming from Akero. If you are contacted by any individual or group using email addresses or other contact information that incorporates “akerotx” but do not use our exact domain, akerotx.com, please submit a report to the FTC.

Opportunity for Secondment to AskBio We're pleased to share an exciting secondment opportunity at AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement. This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio's mission: to advance gene therapy and change the lives of patients around the world. If you're interested in exploring this opportunity, we encourage you to: Speak with your direct manager to discuss your interest and alignment with your development goals. Apply directly using the link provided in the posting. We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. Position Summary The Associate Director, Program Management plays an integral role in advancing AskBio's gene therapy products through clinical development. They will provide comprehensive program management and operational support for the Integrated Product Team (IPT), including creation and maintenance of integrated, end-to-end development plans and timelines. This role partners with the IPT Lead to ensure the program team has clear direction and alignment to execute critical activities ranging from pre-clinical (IND-enabling) studies up through BLA submission (e.g., CMC, regulatory, clinical, medical). This role will be remote based in the US. Job Responsibilities In partnership with the IPT Lead, define scope, objectives, and deliverables for product candidates in stages of clinical development Create and maintain integrated development plans that accurately capture timelines, decision points (i.e., stage gates), resource needs, and budget for multiple clinical programs Track and coordinate critical activities required to advance programs into early-stage and/or registrational clinical studies Provide general operational support to the IPT, including risk identification/mitigation, problem-solving, communication, and contingency planning In partnership with IPT lead, ensure the team is prepared for stage-gates and governance interactions, including content development, stakeholder management, and pre-reads Deliver timely updates to key functional stakeholders, leadership, and governance boards covering program status, risks/mitigation, scope changes, etc. Document IPT meeting minutes, key decisions, risks/issues, and action items Ensure the team communicates effectively and collaboratively, implementing team building techniques where needed to establish and maintain a high-performing teams Facilitate creation of program budgets, resource models and long-range plans Define resource needs (FTEs and financial) for each stage of development Ensure all critical program documentation is organized, accessible, and archived In partnership with the PM Center of Excellence, develop, implement, and champion PM best practices, processes, and strategies within the IPT and supporting functions Assist with implementation of stage-gates and IPT operating model, including education to the organizations through functional team sessions and meetings with stakeholders/teams Minimum Requirements Bachelor's degree in a technical or life science discipline 8+ years of experience within the pharmaceutical/biotechnology industry 4+ years of project/program management experience Excellent written and verbal communication skills with the ability to communicate effectively across disciplines and experience levels, including executive management Experience in planning and/or managing cross-functional aspects of biopharmaceutical product development, including translational and clinical studies Experience with SmartSheets and/or other project planning/management software Ability to mentor, lead, and/or influence partners in a matrixed environment Previous exposure to budgeting and resource management processes Preferred Education, Experience and Skills Advanced degree (e.g., Master's or Doctorate) in a technical or life science discipline Project Management Professional (PMP) or an equivalent certification Prior experience with developing advanced therapies (e.g., cell or gene therapy) Experience working on/with global teams Understands and interprets technical data related to biopharmaceutical product development AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at ************** or sending us an email at *****************.

The Role: The mRNA-4359 Global Brand Lead will drive the global commercialization strategy and operating plan for this asset across multiple solid tumor indications, including preparing for a potential launch in melanoma in 2028. This high-impact role will be responsible for setting the foundation for commercial success of Moderna's first, wholly owned oncology product, and create enduring market leadership for mRNA-4359. In partnership with cross-functional and regional teams, the Global Brand Lead will define positioning, shape stakeholder engagement strategies, and lead go-to-market execution to establish enduring market leadership for mRNA-4359. Here's What You'll Do: Global Commercialization Strategy: Develop and lead the global commercialization strategy for mRNA-4359, ensuring alignment with Moderna's vision, priorities, and market opportunities. Ensure strategic alignment across global functions and priority launch markets to deliver cohesive and locally actionable plans Serve as the single point of accountability for global launch readiness Market Collaboration and Launch Leadership: Partner with key global markets to create launch and commercialization strategies and tactics through regular strategy reviews, tailored resource development, and knowledge-sharing forums, ensuring successful preparation and execution in both pre-launch and post-launch phases. Lead the development and delivery of global tools, campaigns, and resources, such as best practice playbooks and modular content, to empower local market success while maintaining consistency with global strategies. Provide direct launch support to key markets during critical phases to ensure readiness and adaptability. Positioning and Messaging: Lead the development of global product positioning, messaging platforms, and core HCP and patient materials. Collaborate with regional and local teams to create impactful and tailored campaigns that reflect market needs and insights. Team Leadership and Talent Development: As the mRNA-4359 program expands, build, lead, and inspire a high-performing global brand team, ensuring the team has the capabilities and mindset to drive success across indications. Foster a collaborative and agile culture, empowering team members to excel in a dynamic and fast-paced environment. Cross-Functional Collaboration: Partner closely with Clinical Development, Medical Affairs, Market Access, HEOR, CMC, and RWE teams to align on program strategies and key deliverables. Serve as Commercial Lead on program team ensuring key commercial input is provided at all stages of the development process to optimize commercial competitiveness Ensure effective input and collaboration with local and regional commercial teams to address market-specific opportunities and challenges. Lifecycle Management and Innovation: Shape and drive lifecycle management strategies to maximize the long-term value of the mRNA-4359 portfolio. Identify opportunities for product profile improvement and indication expansion. Performance Monitoring and Strategic Insights: Leverage advanced analytics and market research to monitor market performance and inform adjustments to global and regional strategies. Ensure robust feedback loops between global and local markets to address evolving dynamics and unmet patient and stakeholder needs. Here's What You'll Need: Minimum Qualifications: At least 12 years of progressive experience in biopharmaceutical marketing, commercialization, or related roles Bachelor's degree in life sciences, marketing or business Global oncology product launch experience; U.S. launch experience strongly preferred. Proven leadership experience, including managing high-performing teams and delivering results in a global, matrixed environment. Expertise in developing global commercialization strategies, positioning, and HCP and patient campaigns. Strong cross-functional collaboration skills, particularly with Clinical Development, Medical Affairs, Market Access, and Regulatory teams. Demonstrated experience in commercialization across the development lifecycle, from early-stage planning to launch and beyond. Demonstrated ability to partner with regional and local teams to align global strategies and drive execution. Here's What You'll Bring to the Table: Preferred Qualifications: Experience working across diverse cultural and regulatory environments MBA or advanced degree is preferred Demonstrated ability to thrive in fast-paced, innovative environments, with a mindset focused on continuous learning and adaptability. Proven ability to manage and influence senior stakeholders across geographies and functions. Excellent strategic thinking, analytical, and project management skills, with a data-driven approach to decision-making. Experience in managing global complexity and prioritizing in fast-paced, innovative environments. Experience leveraging digital tools and platforms to enhance commercialization strategies. Embodies Moderna's mindset of acting with urgency, accepting risk, and obsessing over learning to drive impact in a fast-evolving oncology landscape. At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Lifestyle Spending Accounts to personalize your well-being journey Family planning and adoption benefits Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities Location-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. -

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. SUMMARY: Centessa continues to expand its CMC group and currently seeks an Executive Director of CMC, to lead our small molecule development programs across all CMC functions. This individual will be responsible for driving technical strategies, managing outsourced manufacturing partnerships, and overseeing all aspects of CMC development from early-to late-stage development and clinical studies. This high-impact leadership role requires a blend of scientific expertise, operational savvy, business acumen, technical efficiency, and strategic foresight. The ideal candidate brings deep experience in small molecule drug development, excels at cross-functional collaboration, and thrives in a growth-stage biotech environment. The Executive Director, CMC will report directly to the SVP, CMC and will have ownership across the CMC function to include strategy, direct reports, team management, cross-functional leadership, and external manufacturing on our pipeline programs. Travel to vendors both domestically and internationally will be required. RESPONSIBILITIES: Strategic Leadership Oversee the implementation of end-to-end CMC strategy across Centessa's development programs Translate development goals into robust CMC plans, ensuring alignment across R&D/early stage, Clinical, Quality, and Regulatory functions Develop long-term development manufacturing strategies that consider Phase 1/Phase 2 forecasting, demand forecasting, investment planning, inventory control, and vendor relationships Proactively identify and mitigate technical, production, and supply chain risks Operational Oversight Act as the CMC team representative member in cross-functional developmental teams Oversee outsourced manufacturing activities, including CDMO contract negotiations and performance management Ensure timely delivery of clinical supply and maintain timelines for Registration/Primary Stability, PPQ/Commercial, and Phase 1/Phase 2 drug substance and drug product batches. Manage the development of budgets and timelines for CMC operations and report regularly to leadership Drive cross-functional meetings and milestone planning to support timely execution across drug substance and drug product for development programs Interface closely with key stakeholders in Quality, Regulatory, Supply Chain, Clinical, Legal, Finance, Project Management, and Non-Clinical teams in the development and execution of CMC plans Assist in developing documents and maintain compliance consistent with GLP and GMP standards for pre-clinical, early- and late-stage clinical development (pre-IND through Phase 3+) Develop and oversee SOPs, protocols/reports, and phase-appropriate specifications for pharmaceutical development and manufacturing activities Oversee technical transfer activities of API and drug product for supply chain resilience Manufacturing and Technical Execution Supervise drug substance and drug product manufacturing and coordination of labeling, packaging, and distribution Oversee sourcing, planning, and logistics for raw materials, APIs, excipients, and required specialized critical reagents or equipment to meet production requirements Manage analytical method development and validation for starting materials, in-process controls, and final release and stability Participate in manufacturing site visits and pre-approval inspection readiness initiatives Identify, select, and manage CDMOs for process optimization, non-GMP and GMP manufacture and supply of API and drug product in support of ongoing pre-clinical and clinical programs, including delivery of scalable and cost-effective manufacturing routes that meet business requirements Regulatory Affairs Collaborate with Regulatory Affairs to support the preparation and submission of CMC sections (INDs, IMPDs, NDAs, etc) Address CMC-related and pertinent cross-functional questions from regulatory authorities and ensure submission and response timelines are met QUALIFICATIONS: Thorough understanding of cGMP requirements for pharmaceutical products Strong organizational, interpersonal, leadership, and decision-making skills Ability to work independently in a fast-paced dynamic environment with multiple projects and competing priorities Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products Excellent organizational skills, project management skills and detail-orientated leadership approach Strong experience with chemical and physical characterization of small molecules Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions Understanding of product quality attributes control strategies as applied to small molecule synthetic processes EXPERIENCE: Master's degree in Organic Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline (PhD preferred). Minimum 15 years of pharmaceutical industry experience including at least 8 years in CMC. Strong track record in CMC leadership across small molecule early-phase development and late-stage filing activities, including management of US and international CDMOs Extensive experience working with CDMOs and managing external partnerships In-depth knowledge of cGMP regulations and best practices in both clinical and commercial manufacturing Demonstrated success in process development, scale-up, and validation Prior experience drafting and submitting CMC content for regulatory filings in the U.S. and international markets, and interacting with global health authorities (IND, IMPD, NDA, MAA) Strong communication, project management, and organizational skills Proven ability to lead cross-functional teams in a fast-paced, evolving environment Strong skills in identifying and resolving critical issues Strong track record in effectively working with senior management Compensation The annual base salary range for this position is $285,000 - $370,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa's long-term success. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. POSITION: Full-Time, Exempt, Flexibility for Remote Work EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. ESSENTIAL JOB FUNCTION: Act as the “CEO” for Kura's lead menin inhibitor, ziftomenib, fostering a sense of mission, creativity and urgency. Lead the Global Program Team: an empowered multi-disciplinary team of leaders Develop near and long-term strategic objectives and recommendations for the asset across all indications from early to late-stage development and ongoing lifecycle management Accountable - the single point of accountability for all Global Program Team activities Define and lead the membership of the core and extended team Focus on full cross-functional business including clinical development, commercial, CMC, finance, and business development Extended partnership with global program management, commercial and development functional leads, external partners, and Senior Leadership Team Work with the team and with senior leaders to define the strategic direction for the asset and plays a key role, driving execution of asset goals, and ensuring alignment and integration among Core Global Program Team and Extended Teams. Form a close partnership with department leads and with program management to build program plans, identify and mitigate risks, capitalize on asset opportunities, manage budgets, and timelines and ensure best practices. Represent the program to internal and external stakeholders, including collaboration partners and the Board of Directors. Lead key program team meetings and serve as a point of escalation for the program to senior leadership. Help build best practices for efficient and effective program teams. Support external stakeholders engagement including Health Authorities, potential strategic partners, vendors and and KOLs. Drive cross-functional collaboration and act as the owner of the Asset Integrated Development Plan Work with corporate affairs on investor communications to optimize external program communications Partner directly with the SVP, Global Program Leadership to lead change and evolution of program and portfolio strategy to enhance decision-making, build high-performing teams, and optimize portfolio decisions across programs JOB SPECIFICATIONS: 15+ years drug development and commercialization experience 10+ years oncology experience, with preference in heme/oncology Prior experience with partnered programs (development and/or commercial) will be valuable Highly visible role focused on cross-functional team leadership, including strategy development, communication and driving tactical delivery of programs Strategy, Project, Program and Portfolio Management, Talent Development, Mentorship and Alliance Management expertise Advanced Degree (MBA, MS, PharmD, PhD) Build trust, transparency, and clear communication plans Connect strategic vision for asset strategy to the competitive environment and company strategy Ability to understand and communicate complex scientific and commercial matters while keeping the big picture in mind and the credibility to engage subject matter experts on details at all levels in the organization Ability to consider and integrate different points of view, new ideas etc.; demonstrates self-awareness and emotional intelligence Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions and departments The base range for a Vice President is $333,000 - $368,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus. #LI-RM1 Kura's Values that are used for candidate selection and performance assessments: We work as one for patients We are goal-focused and deliver with excellence We are science-driven courageous innovators We strive to bring out the best in each other and ourselves The Kura Package Career advancement/ development opportunities Competitive comp package Bonus 401K + Employer contributions Generous stock options ESPP Plan 20 days of PTO to start 18 Holidays (Including Summer & Winter Break) Generous Benefits Package with a variety of plans available with a substantial employer match Paid Paternity/Maternity Leave In-Office Catered lunches Home Office Setup Lifestyle Spending Stipend Commuter Stipend (Boston Office) Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more! Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of relapsed/refractory (“R/R”) NPM1 -mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1 -mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1 -mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1 -mutant and KMT2A -rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA -dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at ******************** and follow us on X and LinkedIn. Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. This position requires approximately 20% domestic/international travel. **** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products. + Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes. + Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. + Experience in CPP application filing through eCATS, 510(j)(3) reporting through next Gen portals is a plus. + Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. + Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools. + Performs other duties as assigned related to CMC RA function. **Qualifications** **Education** : + BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products. + Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications will be a plus. **Skills:** + Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues. + Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval. + Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. + Comprehensive understanding of the global regulatory environment. + Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines. + Strong leadership, communication, and negotiation skills. + Ability to manage complex projects and timelines across multiple regions. + Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + CMC reviewer (assessor) with FDA or EMA will be a plus. **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. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. 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.

Does helping leading organisations achieve world-class performance sound exciting? Well, keep reading, because Competitive Capabilities International (CCi) has an exciting opportunity for a highly experienced Principal to join our Global team. About Competitive Capabilities International (CCi) At CCi, our mission is to help build efficient and sustainable organisations that empower people to do their best work. With our continuous improvement platform and digital applications, we help businesses unlock greatness in everyone on the journey to world-class performance. CCi has 35+ years track record of helping leading organizations build competitive capability through maturity-based best practice implementation. We are immensely proud of our continuous improvement solution, TRACC, which has transformed over 3000 supply chains in more than 75 countries. About the Principal Role As a Consulting Principal, you will play a pivotal role in driving client engagements, overseeing project delivery and developing business opportunities. You will provide strategic guidance, oversee project teams, and build and foster client relationships to drive successful outcomes. This position requires a deep understanding of business strategy, industry expertise, excellent leadership skills, and the ability to foster excellent client relationships, to spot opportunities for up and on sell with our clients. This is a Remote role; we envisage 50% of the time working from home and 50% traveling to clients. CCi has an office in Houston, Texas. We are looking to hear from suitable candidates based in Central, North and East America. 1. Client Relationship management Build and maintain strong relationships with clients by understanding their needs, addressing concerns, and delivering value-added solutions. Function as an experienced and trusted advisor, providing independent opinion on complex client problems & initiatives, and assist with decision making whilst being a conduit into CCI's SME network. Function as a point of escalation for any issues that arise and resolve them in a professional and efficient manner. Agree and document annual client Performance and Practices improvement plans. Conduct minimum quarterly F2F programme review meetings with clients. Play the role as voice of the customer and feed client needs into CCi with a clear business case and ROI for CCi to review and consider. Own and manage the conversations on the NPS Survey Results 2. Business Development and Revenue Generation Expand contacts within client organisation and maintain strong relationships with key decision makers to acquire deep client understanding, determine business plans and future requirements and identify opportunities to on/up-sell the company's services to maximise revenue and manage the client's interests and lifetime value. Develop and maintain an expert knowledge of the client's market, external trends, and the competitive environment, to ensure that the company remains the provider of choice (supported by Global Marketing). Develop a client management and client lifecycle management strategy to maximise revenue potential and to win repeat business from the client, taking platform data into account. Facilitate the allocated client budgeted growth objectives and align the annual client account budget & target setting process with global and allocated client objectives (with support from Finance) Facilitate 3-year forecast and plan in line with client management and client lifecycle management strategy. Ensure that negotiations of key account terms, agreements & SLA's/SoW's result in commercial terms and service standards that are clear and consistent across the client organisation (with support from the Legal Division) 3. Strategic Leadership Provide strategic direction and leadership to consulting teams to ensure alignment with client objectives and overall business goals. Stay abreast of industry trends, best practices, and emerging technologies to provide innovative solutions and thought leadership to clients. Work closely with other Consulting Principals to foster a cooperative internal environment and to share and promote best practices in providing exceptional client experience within the company, to articulate and clarify commercial priorities, and to help refine individual client strategies, within the boundaries of client confidentiality. 4. Project Delivery and Management Oversee the end-to-end execution of consulting projects, including scoping, planning, resource allocation, and quality assurance. Effectively deliver key on-site and above-site consulting services Manage project budgets, forecasts, and profitability, ensuring optimal utilization of resources and cost-effectiveness. Effectively assigning resources, to ensure project success. Identify potential project risks, assessing their impact, and developing mitigation strategies ensuring adherence to timelines, budgets, and quality standards and project outcomes. Ensure prompt resolution of service delivery issues of client concerns through close coordination between Solutions, Consulting and Technology people (information must come from Consulting Principal) Implementing processes to monitor and maintain the quality of project deliverables, ensuring they meet or exceed client expectations. KEY PERFORMANCE INDICATORS KPI 1: Client revenue & profitability and up/on sales targets achieved ($m)/(X) Billable hours KPI 2: Clarity on client needs KPI 3: Client performance (& practice) improvements KPI 4: Scorecard KPI's (& records of people movement for FoF) KPI 5: Client feedback (NPS) KPI 6: Client progress review Requirements QUALIFICATIONS / EXPERIENCE Degree in Engineering Science or Business Administration, Management, or a related field (Master's degree preferred). 8 - 10 years' leadership, management, and/or business development role with experience in supply chain / operations / manufacturing (make) Proven experience in management consulting, with a focus on strategy, operations, or organizational transformation. Business acumen for developing and managing global and allocated market accounts. Strong technical and commercial acumen Expert knowledge of CCI solutions and platform Ideally with proven record of selling in highly complex strategic environments. Able to understand the client's needs and establish clear & mutually beneficial strategic value propositions in co-creation with client. Experience shaping and driving business strategy, able to see the big picture and to shape global strategy. Deep expertise in strategic planning, business analysis, and problem-solving methodologies. Strong planning, organising and project management skills with the ability to effectively prioritise and deliver on multiple tasks and projects. Experience working in cross functional matrix orientated internal structures. Experience in working in multi-cultural environments. Advanced English or allocated market specific language skills Strong leadership and communication skills, with the ability to influence and inspire teams and clients. Excellent project management skills, with a track record of successfully delivering complex consulting engagements on time and within budget. Client-centric mindset with a passion for driving client success and building long-term relationships. Ability to thrive in a dynamic and challenging environment, managing multiple priorities and stakeholders effectively. Proficiency in Microsoft Office suite and project management tools. Professional certifications (e.g., PMP, Six Sigma, CMC) are a plus. PERSONAL ATTRIBUTES Strong relationship building Strategic and commercial orientation Collaborator with advanced people skills, who can engage with people at all levels inside and outside the company and involve and collaborate with key stakeholders. Able to negotiate with both internal and external stakeholders at senior levels focused on partnership and client experience. Able to gain trust quickly and be direct and persuasive as well as diplomatic. Analytical ability to analyse and improve current practices, performance, and company processes. Ability to identify opportunities and to build robust plans and winning proposals. Proactive and drives hard for results. Takes needed action to meet targets. Professional and credible with high standards of personal presentation Willingness to travel extensively in the role to client sites. Role Models CCi's Behaviours: Own It, Solve It, Act Now, Diamond Focus

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity The Director, External Manufacturing (CMC) will lead and manage outsourced manufacturing operations supporting Praxis's clinical and future commercial programs. This role will oversee Contract Development and Manufacturing Organizations (CDMOs) responsible for drug substance (API) and drug product manufacturing, ensuring high-quality, compliant, and timely supply of clinical materials. The ideal candidate is a strategic, hands-on CMC leader experienced in managing external partnerships and driving operational excellence in a dynamic biotech environment. Primary Responsibilities External Manufacturing Oversight Lead the strategy, selection, and management of CDMOs for both drug substance and drug product manufacturing. Serve as the primary operational interface between Praxis and external manufacturing partners. Oversee technology transfer, process scale-up, validation, and clinical supply readiness. Establish and maintain robust Quality and Technical Agreements with manufacturing partners. Manage and optimize the end-to-end supply chain process, including raw materials procurement, production planning, logistics, inventory management, and distribution. Lead supplier qualification, monitoring, and performance evaluations, addressing risks and identifying opportunities for improvement. Negotiate contracts and pricing agreements with suppliers and CMOs to achieve cost-effective outcomes while maintaining supply security. CMC Operations and Program Support Collaborate closely with Process Chemistry, Formulation, Analytical, Quality, and Regulatory teams to ensure seamless execution of CMC deliverables. Support CMC development strategies aligned with clinical timelines, regulatory expectations, and company objectives. Manage manufacturing planning, scheduling, and inventory to ensure uninterrupted clinical supply. Governance, Compliance, and Continuous Improvement Ensure all outsourced manufacturing is performed under appropriate GMP and regulatory standards. Implement key performance indicators (KPIs) and governance mechanisms to monitor and improve CDMO performance. Proactively identify and mitigate technical and operational risks across the external supply network. Drive operational excellence and process improvements to enhance efficiency and compliance. Qualifications and Key Success Factors Advanced degree preferred in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; bachelor's degree with extensive relevant experience considered. 15+ years of progressive CMC or manufacturing experience within the biopharmaceutical industry, including ≥8 years managing external manufacturing relationships. Proven experience in managing global CMC supply chains for commercial products in a regulated environment. Includes strong understanding of GMP, GDP, and ICH guidelines and their application in a commercial setting. Demonstrated experience overseeing both drug substance and drug product manufacturing at clinical or commercial scale. Excellent negotiation and vendor management abilities including experience working with CMOs and managing third-party relationships. Proven ability to manage complex projects and external relationships with technical and business acumen. Ability to navigate complex regulatory and compliance requirements. The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Compensation & Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let's achieve the impossible together! To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience. Annualized Base Salary $210,000 - $230,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant's first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum. Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. A phase 2 trial is currently ongoing to further characterize safety and efficacy. As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need. For more information, please visit ************************** Director/Senior Director, Drug Product Development and Manufacturing Summary: Pulmovant is seeking a Drug Product Lead to help drive the development, scale-up of Phase 3 and commercial manufacturing of our dry powder inhaled small-molecule inhalation program through external CDMOs. This role focuses on managing late-stage clinical development activities (Phase 2/3) and ensuring a smooth transition to commercial manufacturing. This is an exciting and visible role for a highly qualified and motivated individual. The successful candidate will lead cross-functional teams involving drug substance, clinical, non-clinical, quality and regulatory partners, and work closely with external partners to ensure timely delivery of high-quality drug product in compliance with global regulatory standards. The ideal candidate will be detail driven and have a deep understanding of inhalation drug product process development, technical transfer, regulatory requirements, CDMO management and a proven track record in managing and driving project success. Key Duties and Responsibilities Serve as the Drug Product Technical Lead for the inhalation dosage form, accountable for product performance, manufacturability, and lifecycle management. Lead Phase 3 process characterization, validation, and registration batch execution at CDMOs. Provide scientific oversight of formulation development, device compatibility, and container-closure system. Partner with other functional area leads to ensure successful method validation, product specifications, and stability studies to support regulatory filings. Partner with Quality, Regulatory, and Supply Chain to ensure GMP compliance and pre-approval inspection (PAI) readiness. Represent drug product in CMC team meetings, regulatory submissions (Module 3), and health authority interactions. Manage technology transfer when needed, manufacturing documentation, and process validation protocols/reports. Collaborate closely with other functional areas (drug substance, analytical development, and QA) to ensure a robust control strategy. Provide technical guidance and mentoring to junior staff or matrixed contributors as needed. Education and Experience 15+ years of experience in inhalation product development (preferably dry powder inhalation). Demonstrated success advancing an inhalation product through late-stage development (Phase 2b/3) and into registration. Hands-on experience with formulation, process scale-up, drug-device compatibility, and aerodynamic performance testing (APSD, delivered dose). Strong working knowledge of cGMPs, ICH guidelines, and regulatory expectations for combination products. Proven track record of managing CDMOs, including oversight of technical deliverables, timelines, and budgets. Familiarity with Module 3 CMC documentation, process validation, and stability data requirements. Experience preparing for or supporting NDA/MAA submissions for inhaled products preferred. Strong data analysis and risk assessment skills (e.g., QbD, DoE, FMEA). Exceptional collaboration and communication skills - ability to influence across functional boundaries and external organizations. Comfort operating in fast-paced, lean, biotech environments with high accountability. Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!

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 **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders. Leads and/or coaches a team or individual team member of regulatory CMC professionals. The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness. Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability. **Responsibilities and Accountabilities:** **Strategic Leadership:** + Define and implement global CMC regulatory strategies with a strong focus on North American requirements. + Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU. **Policy & Advocacy:** + Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts. + Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams. **Cross-Functional Collaboration:** + Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies. + Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions. **External Engagement:** + Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations. + Lead advocacy initiatives for innovative technologies and precedent-setting projects. **Operational Excellence:** + Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes). + Ensure consistency and quality in dossier preparation across regions. **Expected Key Accountabilities from Global Regulatory Aspects** + Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions. + Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders. + Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities. + Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders. + Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs. + Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects. + Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation. + Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas. + Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training. + Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions. + Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility. **Required** + Advanced degree in Chemistry, Engineering or equivalent degree (PhD, PharmD, MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the pharmaceutical or biotech industry, with significant exposure to North American regulatory requirements. + Proven track record in developing and implementing global CMC strategies and influencing regulatory policy. + Strong knowledge of FDA, ICH and global guidelines; prior experience in ICH initiatives highly desirable. + Expert technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and an in-depth knowledge of global regulatory CMC submission requirements, with a strong understanding of the application of ICH and other guidance. + Exceptional communication and leadership skills; ability to influence internal and external stakeholders. + Experience representing companies in trade associations and industry forums. + Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope. + Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral + dosage forms) is required. + Demonstrated track record for successful interactions with global health authorities related to CMC submissions. + Ability to navigate a global organization and to act globally and regionally as appropriate. + Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders in high impact situations. + Proven leadership skills is preferred. **Salary Range** $170,450 - $267,850 (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-SS Category Regulatory CMC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Career CategoryRegulatoryJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Regulatory Policy and Intelligence - US Director Live What you will do Let's do this. Let's change the world. Global Regulatory Policy team engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important policy issues within the U.S. aligned with Amgen's goals and priorities. In this vital role you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business and will serve as a U.S. Policy Lead for Global Regulatory Policy and Intelligence. Key Responsibilities include: Masters a range of regulatory policy topics and provides strategic U.S> regulatory policy advice and guidance related to Amgen's product portfolio, including a focus on artificial intelligence and emerging regulatory technologies (e.g., cloud-based submissions) Engages US regulatory authorities, industry, and professional associations at the policy level Leverages key relationships with FDA staff and industry and trade association colleagues to advance Amgen's position related to regulatory policy Coordinates the implementation of new U.S. regulatory policy and guidance across Amgen functions Engages cross-functional teams to develop strategic/long-term plans for the development and implementation of policies Masters a range of regulatory policy topics as assigned, including topics such as Chemistry, Manufacturing, and Controls (CMC), Precision Medicine, and Combination Products. Leads the development and execution of strategic plans for each assigned policy area. Ensures that Amgen's regulatory policy positions are successfully represented to inform policy development and implementation Fosters a reputation with regulators as being science-based, reliable and trustworthy by advocating sound for policies Provides internal stakeholders (e.g., Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory policy perspective Assists and advises senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans Assists in creating the necessary infrastructure/processes for developing the regulatory policy and intelligence function Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The regulatory policy and intelligence professional we seek has a deep knowledge and understanding of the U.S. regulatory environment and can provide insights to internal stakeholders, as well as shape the external regulatory environment to support Amgen priorities and has these qualifications Basic Qualifications: Doctorate degree and 4 years of related experience Or Master's degree and 7 years of related experience Or Bachelor's degree and 9 years of related experience Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 188,796.00 USD - 222,457.00 USD

The Role This is a summer internship opportunity with Moderna Global Drug Product Operations team from June to August 2026. Applicants must be available for the entire duration of the internship. Start date will be June 1, 2026. Moderna's Global Drug Product (DP) Operations is looking for top talent in the Strategic Operations team to design and pilot a standardized Supply Risk Management framework for Drug Product (DP) Operations. This project will cover both internal manufacturing sites and external Contract Manufacturing Organizations (CMOs), with the goal of identifying, assessing, mitigating, and governing a broad range of risks that can have an impact on our ability to deliver mRNA medicines to patients. The DP Supply Risk Management framework will play a key role within Manufacturing Strategy, becoming a central piece in our efforts to ensure Production Continuity and Resiliency. The internship offers a unique opportunity to work in a highly cross-functional set-up and contribute to enterprise-level processes while gaining hands-on experience with Moderna's manufacturing network, performance management, continuous improvement, and PMO governance. Here's What You'll Do * Design and pilot a cross-functional Supply Risk Management Framework for Global DP Operations, including risk categories, risk evaluation criteria, scoring methods, and governance mechanisms. * Develop a Risk Register template with both Site/CMO-level and consolidated network views. * Conduct the first network-wide risk assessment, piloted across selected sites and CMOs. * Together with the respective Operations Leaders and cross-functional team members, build a Mitigation Action Plan with assigned owners, timelines, due dates, and expected impact. * Create a Governance Framework (dashboard, heat map, cadence of reviews, escalation path) to oversee mitigation actions and monitor risks. * Ensure the framework seamlessly integrates with enterprise processes such as Quality Management Review (QMR), Supply Chain Management processes, CMC Business Continuity, HS&E policies, Procurement policies and standards and CMO Management. * Present findings and recommendations to cross-functional stakeholders and the Global DP Operations Leadership Team. Here's What You'll Need (Basic Qualifications) * GPA of 3.5 on a 4 scale or equivalent with a degree focus in Operations, Supply Chain, Strategy, or related discipline. * Strong analytical, problem-solving, and data interpretation skills. * Ability to manage projects independently and collaborate in a fast-paced, cross-functional environment. * Excellent written and verbal communication skills. * At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. * This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work. Here's What You'll Bring to the Table (Preferred Qualifications) * Prior experience or coursework in risk management, supply chain, or manufacturing operations. * Demonstrated ability to structure ambiguous problems and deliver clear, actionable insights. * Strong interpersonal skills and comfort engaging with senior stakeholders. * A desire to contribute to Moderna's mission in a high-growth, transformational environment that values being Bold, Relentless, Curious, and Collaborative. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our co-op benefits are designed to support you during your time with us -at work, at home, and everywhere in between. * Free premium access to meditation and mindfulness classes * Subsidized commuter benefits * Generous paid time off, including vacation, sick time, holidays, volunteer days, and a discretionary year-end shutdown * Location-specific perks and extras The salary range for this role is $20.00 - $60.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. *

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Manager, Analytical Development to manage and coordinate analytical activities on multiple early and/or late phase clinical development programs. The ideal candidate will be a team player comfortable working on a small team in a fast-paced environment and with contract manufacturing and development organizations. Excellent time management skills and communication will be key in succeeding in this role. This position requires an extensive hands-on laboratory experience using a broad array of analytical instrumentation. This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. Job Responsibilities and Duties include, but are not limited to, the following: Work closely with the CMC team (and specifically the head of analytical development) to manage and coordinate analytical activities on multiple early phase drug substance (40%) and drug product (60%) small molecule solid oral formulation programs Manage early and/or late phase drug substance and drug product analytical activities at contract development laboratories (method development, method qualifications/validations, method transfers, analytical investigations support) Review and/or author analytical technical/development and method qualification/validation reports and raw data as well as release and stability data packages Assist in authoring CMC sections for regulatory submissions Manage drug substance and drug product stability programs (QC and technical review of stability data packages that includes raw data, and stability data trend analysis) Assist in the development of standard operating procedures Manage reference materials and reference standards inventory and (re)qualification testing Requirements / Qualifications Bachelor's degree in Analytical Chemistry or Chemistry or related field with 5+ years' experience or MS/PhD with 3+ years of GMP and GLP-related pharmaceutical industry experience in small molecule solid oral formulation analytical development Knowledge of drug product solid oral dose formulations Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size Functional understanding of small molecule analytical development and associated regulatory and quality requirements Hands on experience with LC-MS/MS and GC-MS is a plus Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles Experience, Knowledge and Skills Demonstrated experience in managing outsourced analytical activities Demonstrated experience in QC data review of release and stability data packages for both drug substance and drug product Experience working on commercial stage products highly valued Excellent verbal and written communication skills Excellent problem solving and interpersonal skills Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities. Ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently Flexibility to accommodate multiple time zones as needed Preference to energetic candidates with a desire to think “outside the box” Willingness to travel periodically as needed Salary & Benefits The anticipated salary range for this role is $120,000 - $135,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.