Post job

AGC Biologics jobs in Longmont, CO - 345 jobs

  • Center Manager in Training - Relocation Required

    Biolife Plasma Services 4.0company rating

    Denver, CO job

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **Senior Operations Management Trainee (Senior OMT)** **About BioLife Plasma Services** Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. _BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd._ _Equal Employment Opportunity_ Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a **Senior Operations Management Trainee** at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. **Our growth is your bright future.** Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. **_A typical day for you may include:_** + **Continuous Learning & Development:** The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. + **Team Management:** You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. + **Career Advancement:** Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. + **Supportive Teamwork:** You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. + **Exceptional Customer Service:** Retain donors by creating a positive donor experience. You may also assist with production. + **Travel Opportunities:** Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. **REQUIRED QUALIFICATIONS:** + Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. + 3-5 years of experience leading medium to large teams (20+ direct reports) + Up to 90-100% travel during the Trainee Program + Ability to walk and/or stand for the entire work shift + Willingness to travel and work at various BioLife locations across the country + Ability to work evenings, weekends, and holidays + Have a valid driver's license for the entire duration of the program + Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees + Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. + Fine motor coordination, depth perception, and ability to hear equipment from a distance + Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear **PREFERRED QUALIFICATIONS:** + Associates or Bachelor's Degree + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated or high-volume retail environment + Excellent interpersonal, organizational, technical, and leadership skills **About BioLife Plasma Services** Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. _BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd._ _Equal Employment Opportunity_ \#LI-Remote **BioLife Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** USA - NJ - Virtual **U.S. Base Salary Range:** The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** USA - NJ - VirtualUSA - NJ - Deptford, USA - NJ - Egg Harbor **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** Yes
    $46k-65k yearly est. 5d ago
  • Job icon imageJob icon image 2

    Looking for a job?

    Let Zippia find it for you.

  • Director of Business Development

    Prometheus Materials 4.7company rating

    Boulder, CO job

    Prometheus Materials develops innovative sustainable building materials to drive the transition toward a carbon-negative future. Using nature-inspired processes, the company utilizes microalgae to produce its ProZERO™ line of carbon-negative supplemental blends, designed for ready-mix applications, manufactured products, and licensed material solutions. These cutting-edge materials address the environmental challenges of traditional construction while offering scalable solutions for concrete manufacturers. Role Description The Director of Business Development is responsible for identifying and developing the sales and marketing strategies leading to long-term, profitable growth. You will evaluate and execute new business opportunities which align with Prometheus Materials' overall market growth strategies. This position will work closely with distributors, vendors, and customers. Additionally, close collaboration with internal business units (biotechnology, research and development, manufacturing, and product management) will be essential to the success of the Director of Business Development. Responsibilities: This is a summary of activities and is not intended to be all-inclusive of all responsibilities. · Develop, own, and execute a formal business plan aligned with company objectives · Develop, maintain, and track product backlog and bid activity · Establish revenue goal KPIs and deliver results · Manage strategic relationships to maximize revenue performance · Create and manage key account plans, including defined goals, activities, and timelines · Communicating regular updates of key performance indicators, including volume, revenue, and strategic initiatives · Identify, secure, grow, and manage key licensing opportunities across multiple industries · Research, analyze, and implement key market trends within low-embodied carbon building materials · Monitor and maintain competitive intelligence, including competitor products, pricing strategies, and development activities · Regularly review the sales cycle and implement continuous improvement strategies · Travel up to 40% as required Qualifications: Use your existing network or develop a robust network of key stakeholders to increase market awareness, market share, and success of the formal business plan. · Bachelor's degree in Business or a related field, or equivalent experience · Minimum of 5 years of experience in sales, marketing, or product management · Experience within the building materials industry preferred (e.g., sand and gravel, cement, ready mix, or admixtures) · Proven experience collaborating with industry experts (Architects and Engineers) · Working knowledge of key high-level industry standards relating to cement, concrete, and aggregates · Demonstrated experience developing, managing, and executing sales strategies to drive revenue growth · Strong understanding of business-to-business sales cycles, sales strategies, and key performance metrics · Experience building, leading, and managing multi-dimensional sales team · Proficiency with Customer Relationship Management (CRM) software and sales reporting · Solid financial and business acumen, including budgeting, forecasting, and pricing strategies · Strong negotiation, presentation, and facilitation skills · Knowledge or experience with sustainability initiatives, LEED certification, and carbon reduction targets Please send resume and cover letter to ****************************
    $80k-126k yearly est. 4d ago
  • Production Technician I

    STAQ Pharma Inc. 3.7company rating

    Denver, CO job

    Job Description This entry-level Operations position functions as part of the Production Team and independently performs labeling, visual inspection, and other duties, such as cleaning, restocking, as required and/or assigned. This position functions primarily in a controlled non-classified (CNC) environment and requires the individual to wear appropriate PPE. Performs all job functions in adherence with cGMP, company policies, and any other quality or regulatory (e.g., OSHA, DEA, FDA, etc.) requirements. Duties/Responsibilities: SAFETY Strictly adheres to all regulatory requirements, health and safety (e.g., OSHA, EPA, RCRA) requirements, procedures, work instructions, and corporate policies. Immediately stops any task that is determined to be an imminent hazard. Promotes and demonstrates safe work practices and adhere to PPE requirements. Safely handles chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrates physical ability to lift a minimum of 50 lbs. and push/pull pallets, product containers, etc., multiple times per shift. PRIMARY RESPONSIBILITIES: Assist with non-classified area cleaning and maintenance as required. Executes all processes as defined in the batch record, procedures, and work instructions consistent with regulatory/cGMP requirements. Performs Visual Inspection of finished products. Performs Labeling and Packaging of finished products. Maintains training and qualification in all areas as required. Demonstrates basic troubleshooting skills. Uses equipment according to procedures and work instructions. Completes cGMP documentation reviews as required or assigned. Performs other duties as assigned. Demonstrates ability to recognize and respond to potential deviations from the defined process. Required Skills/Abilities: Demonstrates ability and motivation to progress to a Production Technician II and/or master multiple processes within assigned work area. Demonstrates accountability by arriving at work at scheduled start time, prepared to work in the CNC or classified environment for most of each shift. Recognizes individual and team deviations and accepts responsibility for making corrections and improvements. Demonstrates integrity by maintaining high ethical standards and treats all employees with trust, respect, and professionalism. Speaks up and holds others accountable by providing constructive feedback. Ensures patient safety by understanding individual and team impact on product quality. Participates effectively on a diverse and high performing team. Remains open to new ideas and perspectives, communicate across shifts as required, and complies with procedures to create a safe work environment. Demonstrates motivation by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrates courage and innovation by speaking up about viable options for improvements and supporting a path for implementation. Education and Experience: High School Diploma or equivalent. Must pass drug screening and vision screening. Must speak, write, and read English. Must be a team player. 1+ years of continuous work experience Prior experience in a regulated manufacturing industry. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands Must have excellent attention to detail. Physical Requirements: Must be able to left up to 50 pounds at times. Prolonged periods of standing/sitting. Working hours are Tuesday through Friday, 3:00pm - 1:30am.
    $23k-36k yearly est. 3d ago
  • Manufacturing Operator I

    Cambrex 4.4company rating

    Longmont, CO job

    Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Manufacturing Operator will properly operate solid dose manufacturing equipment to perform production of drug products. Personnel in this position will operate manufacturing processing equipment by following standard operations procedures and batch records in accordance with FDA cGMPs. The main focus for personnel in this position will be responsible to operate, set-up and break down production equipment, clean production areas and maintain consumable supplies. Responsibilities Properly operates, sets-up and breaks-down production equipment. Maintains cGMP suites readiness for manufacturing activities including consumable allocation, cleaning of work area and tools and equipment disinfection. Performs minor mechanical maintenance of equipment. Maintains consumable supply inventory. Washes small utensils and glassware for department. Properly performs drug product manufacturing, packaging and labeling activities under direct supervision. Follows written procedures. Distributes clinical supplies. Clearly and accurately documents activities for production records and manufacturing equipment (production notebooks, cleaning logs, maintenance logs, etc) Perform basic math calculations. Assists with batch records for cGMP manufacturing under direct supervision. Other duties as assigned. Qualifications/Skills Mechanical aptitude is preferred Moderate knowledge of manufacturing equipment for cGMP environment Ability to wear Personal Protective Equipment (PPE). Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers. Willingness to work with highly toxic and controlled substances. Ability to conduct routine in-process testing and visual inspections and identify out-of-specification conditions. Ability to work in a regulated environment (FDA/DEO/OSHA) and strictly follow procedures. Effectively communicates both verbally and in writing. Ability to read and comprehend detailed written instructions. Ability to clearly and concisely document al work activities in a timely manner utilizing existing forms and records. Writes legibly. Perform basic math functions to include product accountability and material adjustment calculations and rounding. Basic computer skills. Ability to move materials throughout facility using appropriate methods and equipment. Operate machinery and read process control instruments to ensure proper operation. Identify operations problems when they occur. Ability to clean rooms, equipment and tools for use in a cGMP environment. Perform basic troubleshooting applications. Provide basic training to other operators after learning a skill set. Minimal interaction. On an as needed basis. Exhibited leadership skill in individual area of expertise. Must have the ability to work overtime when required. Must adhere to attendance policy of Avista. Expected to arrive for shift on time and contact management immediately if unable to attend work for any period of time. May directly interact with auditors during a scheduled inspection. Ability to work effectively within a team environment. Education, Experience & Licensing Requirements High school diploma or equivalent with 0-5 years of experience in a regulated environment. The hiring range in Colorado for this position is $27/hr. -$33/hr. ; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Supervision Received: Works under limited supervision. Physical Demands, Work Environment, and Travel Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop. The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required. Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. Travel: Little to no expected travel time. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-SK1High school diploma or equivalent with 0-5 years of experience in a regulated environment. The hiring range in Colorado for this position is $27/hr. -$33/hr. ; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Properly operates, sets-up and breaks-down production equipment. Maintains cGMP suites readiness for manufacturing activities including consumable allocation, cleaning of work area and tools and equipment disinfection. Performs minor mechanical maintenance of equipment. Maintains consumable supply inventory. Washes small utensils and glassware for department. Properly performs drug product manufacturing, packaging and labeling activities under direct supervision. Follows written procedures. Distributes clinical supplies. Clearly and accurately documents activities for production records and manufacturing equipment (production notebooks, cleaning logs, maintenance logs, etc) Perform basic math calculations. Assists with batch records for cGMP manufacturing under direct supervision. Other duties as assigned.
    $27-33 hourly Auto-Apply 23d ago
  • Shipping Specialist

    STAQ Pharma Inc. 3.7company rating

    Denver, CO job

    Job Description This a light to medium experience required position that involves running and managing all the shipping and receiving activity at a cGMP facility. Product and materials will be required to be purchased, accepted, logged, and shipped on a daily basis. Good organization and attention to detail will be required by this role. SAFETY • Safely handles chemicals, corrosives, solvents, and other pharmaceutical compounds • Ensures compliance with regulatory agencies such as OSHA, EPA, RCRA and company Guidelines • Demonstrate physical ability to lift up to 50 pounds and push/pull pallets, product cans, etc. multiple times per shift. • Demonstrates ability to stand and walk for extended periods of time. CORE TASKS • Physically “accepts” deliveries, inspects for damage, and matches them to open PO's. • “Receives” items into our inventory management system. • Properly documents and tracks all product coming in and going out of facility on a daily basis. • Ships product when a sales order is communicated by the sales department. • Maintains cleanliness and organization of dock area as directed by the Quality Department. • Assists with quarterly inventory counts and reconciliations. • Manages waste disposal. • Assists other departments as bandwidth allows, especially the Material Handler position. • Strictly adheres to cGMP's, health and safety requirements, procedures and corporate policies • Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: DEA, FDA, etc.) • Other duties as assigned. VALUES & BEHAVIORS • Demonstrates Innovation abilities by identifying and speaking up about possible improvements and identifying more efficient ways of doing things. • Operates with Integrity by maintaining high ethical standards, cares, shows trust and respect with all employees • Collaborates to create or participate effectively on diverse and high performing teams, is open to new ideas and perspectives, communicates across shifts, and demonstrates a safe work environment • Demonstrates a passion to Perform by meeting personal and departmental goals, gains knowledge to display increasing independence, instills confidence in ability to perform required tasks, and progresses on qualifications within reasonable timelines • Demonstrates Courage by speaking up, accepts constructive feedback, and takes accountability for mistakes and make necessary corrections
    $30k-38k yearly est. 31d ago
  • Quality Control Specialist

    STAQ Pharma Inc. 3.7company rating

    Denver, CO job

    Job Description The Quality Control Specialist is a critical member of the team, ensuring the production and distribution of high-quality, sterile pharmaceutical products in compliance with FDA regulations, cGMP guidelines, and USP standards. This role involves conducting rigorous testing, inspections, and documentation throughout the manufacturing process to verify product integrity, sterility, and accuracy. Key responsibilities include performing laboratory analyses, environmental monitoring, and equipment calibration; reviewing and maintaining quality control records; and collaborating with cross-functional teams to identify and address quality issues. The specialist must remain updated on regulatory changes and implement continuous improvement initiatives to enhance operational quality and efficiency. Duties/Responsibilities: Works effectively and efficiently in a team environment. Conduct routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility, as needed Incubation and enumeration of samples related to environmental monitoring processes, as needed. Conduct morphology assessment on appropriate samples at the conclusion of the incubation term, as needed. Perform review and release of raw materials, API, and excipients. Coordinates third party sample submission. Demonstrates the ability to perform detail-oriented work with a high degree of accuracy. Conduct investigations pertaining to OOS/OOT of raw materials, in-process, and finished product results with production personnel and/or supplier. Assists with all aspects of the quality system, such as change control, investigations, CAPA, and validation systems to ensure compliance and timely completion of assigned activities. Compiling data for quarterly report review. Review and release of finished product testing results. Generation of Certificate of Analysis and Finished Good Forms for batch release. Participate in product development meetings and represent Quality Control. Assist with the development, management and improvement of quality system processes and procedures to ensure compliance with applicable laws, regulations, and company standards in support of cGMP for pharmaceutical compounding. Lead/support audits (internal and external) to ensure compliance to CGMP regulations and internal procedures. Performs other duties as assigned. Required Skills/Abilities: Excellent verbal and written communication skills. Excellent interpersonal and customer service skills. Excellent sales and customer service skills. Excellent organizational skills and attention to detail. Excellent time management skills with a proven ability to meet deadlines. Strong analytical and problem-solving skills. Strong supervisory and leadership skills. Ability to prioritize tasks and to delegate them when appropriate. Ability to function well in a high-paced and at times stressful environment. Proficient with Microsoft Office Suite or related software. Education and Experience: BS/BA in Microbiology, Chemistry, or a relevant field/or equivalent experience. 2-5 years of Quality Control experience. Experience in a cGMP environment. Previous pharmaceutical experience. Familiarity with 21 CFR Part 11/210/211. Experience with aseptic manufacturing environments. Comfortable in a fast-paced, small company environment and able to adjust workload based upon changing priorities. Physical Requirements: Demonstrates ability to walk and stand for prolonged periods of time. Demonstrates ability to sit/ stand at a desk and working on a computer. Must be able to lift up to 15 pounds at times. Timeline: We will be accepting applications on an ongoing basis until position is filled.
    $27k-37k yearly est. 31d ago
  • Senior Director, Early Development Team Lead _Immunology

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Denver, CO job

    The Early Development Team (EDT) Immunology Lead is a critical role to the sustainability and success of the pipeline, and ultimately bringing medicine to patients with unmet medical needs. SThe Early Development Team (EDT) Lead is a critical role - working to deliver Otsuka's pipeline and bring differentiated medicines to patients. The EDT Leader will lead asset focused multi-disciplinary teams from pre-clinical through demonstration of clinical proof of concept through to late stage development. The EDTL will be accountable to Early Development leadership and will lead EDTs to: (i) craft a vision, strategy and development plan for early assets (ii) develop a set of objective progression criteria for each asset advancing through the Otsuka pipeline (iii) deliver the programs to the organization and (iv) evaluate opportunities to build value in the pipeline. **Key Role Accountabilities:** _Strategy & Execution_ + Leads Early Development teams to deliver early phase assets through clinical PoC, that supports go/no-go decisions for further development.- Engages EDT members and cross company stakeholders to devise and implement an agreed development strategy for early phase portfolio assets through clinical PoC, aligned with late phase Development and Commercial.- Effectively engages with and utilizes governance and advisory bodies to agree, revise and progress asset development plans proposed by the EDTs.- Continually analyzes, progresses, and engages EDT members and stakeholders to solve problems and deliver data-driven decisions.-Ensures that the EDT delivers to Full Development assets that meet robust Target Reimbursable Product Profiles that can achieve pricing, reimbursement, access and puts forward recommendations when these criteria cannot be met.- Ensures the process and output of the team meets set milestones, within timelines & budget while remaining cognizant of opportunities to streamline development without compromising quality.- Engages senior leaders and functional area stakeholders to ensure alignment of program strategy and operational plans with functional area capabilities. **_Leadership & Matrix Alignment_** + Works with EDT to set goals and objectives for asset development; ensures aligned functional and individual objectives (for self and team members) across the matrix to accomplish the asset development plan.- Oversees relevant sub-teams and ensures clear goals and objectives are in place, provides feedback and coaching, and holds sub-team leaders accountable for key deliverables.- Facilitates objective and effective decision making among team members.- Builds productive relationships with functional heads of all groups that interact with the EDT, and partners with them to advance the EDT goals and secure resources.- Communicates key program information, risks, and milestones, and ensures information flow across key stakeholders, governance teams, functional leaders, team members, etc. **Experiences and expertise required:** + MD, PhD, DVM, PharmD, MBA, or equivalent advanced biology degree- Experienced drug developer with 10+ years experience in the drug development process, preferably with experience in early phase development covering both biologics and small molecule- Experience in managing and leading high performance, cross-functional teams (Matrix) or complex organizations. - Objective matrix team leader with demonstrated ability to frame issues, ask the right clarifying questions, and rationalize decisions in a cost disciplined manner, with an enterprise view- Strong understanding of relevant regulatory health authority expectations and regulations for drug development- Working knowledge of all functional areas of exploratory development, including, CMC (small molecules and biologics), biology, toxicology, clinical pharmacology, ADME/DMPK, early clinical development, etc.- Ability to create a clear purpose, global vision, strategies and key priorities for competing successfully in the evolving pharmaceutical and health care industry- Ability to multitask across multiple exploratory development assets.- Demonstrated ability to successfully and effectively cooperate, collaborate and work across functional boundaries- Ability to review and interpret scientific data and incorporate emerging information, feedback and scientific progress (internal and external) into development actions. **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 $230,720.00 - Maximum $345,000.00, 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.
    $230.7k yearly 4d ago
  • MTM Pharmacist

    Pharmacy Careers 4.3company rating

    Aurora, CO job

    MTM Pharmacist - Help Patients Get the Most Out of Their Medications Are you passionate about patient care and looking for a role with strong clinical impact and better work-life balance? We're seeking MTM Pharmacists (Medication Therapy Management) to join our growing team. In this role, you'll use your clinical knowledge to optimize therapy, reduce costs, and improve patient outcomes-all while enjoying the flexibility that MTM careers often provide. Key Responsibilities Conduct comprehensive medication reviews (CMRs) with patients to identify medication-related problems. Provide targeted medication interventions (TMEs) and follow-up to support adherence and safety. Collaborate with prescribers, health plans, and care teams to resolve therapy issues. Document interventions clearly and maintain compliance with MTM program requirements. Educate patients on safe, effective use of their medications and address barriers to adherence. What You'll Bring Education: Doctor of Pharmacy (PharmD) or Bachelor of Pharmacy degree. Licensure: Active and unrestricted pharmacist license in the U.S. Experience: Retail, hospital, ambulatory care, or prior MTM experience is a plus-but all licensed pharmacists are encouraged to apply, including new grads. Skills: Strong communication, patient counseling, and ability to work independently. Why This Role? Flexibility: Many MTM pharmacist positions offer remote or hybrid work. Impact: Directly improve patient outcomes by reducing adverse events and optimizing medication therapy. Growth: Build expertise in managed care, ambulatory care, and clinical pharmacy pathways. Rewards: Competitive pay, benefits, and opportunities to expand into roles like prior authorization, clinical review, or population health. About Us We partner with health plans, PBMs, and healthcare organizations nationwide to deliver high-quality MTM services. Our pharmacists are at the center of patient care, making medications safer, more effective, and more affordable. Apply Today Ready to advance your pharmacy career? Apply now for our MTM Pharmacist opening and help patients achieve better health outcomes.
    $78k-97k yearly est. 60d+ ago
  • Imaging Project Coordinator - Master's/PhD

    Medpace 4.5company rating

    Denver, CO job

    Our imaging services are growing rapidly, and we are currently seeking a full-time, office-based Imaging Project Coordinator to join our team. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities * Compile and maintain project-specific status reports and project timelines associated with Imaging studies; * Maintain inventory of imaging supplies for study sites; and * Interact with study sites and internal associates. Qualifications * Bachelor's Degree (required), Master's or PhD (preferred) in Biomedical Engineering * Prior research related experience is preferred; and * Excellent computer, organizational and communication skills. Compensation A target salary range of $80,000-$120,000 with potential for bonus awards. Your compensation will be based on your skills and experience. Medpace offers the following benefits for full-time positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, pet insurance, and reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations). Applications will be accepted on an ongoing basis. For more details, please discuss with your recruiter. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Denver Perks * Denver Office Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Structured career paths with opportunities for professional growth * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * RTD Eco Pass * Secure bike storage room Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $80k-120k yearly Auto-Apply 23d ago
  • Medical Science Liaison - Rare Diseases West

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Denver, CO job

    **Customer Engagement Model** Otsuka America Pharmaceutical, Inc. has launched a new customer engagement approach designed to better deliver on patient, caregiver, and HCP needs in an evolving healthcare environment. The new model is built around where patients get their care-locally, with the intent to better serve patients, caregivers, and healthcare providers, delivering a higher quality experience that ultimately is focused on improving patient care. The local "ecosystem approach" creates a unified focus among account management, medical, patient access and market access to engage local healthcare systems and identify opportunities to improve the patient experience. Through this matrix model, customers will now experience more coordinated and seamless care with digital-enabled support to bridge care gaps. In Otsuka's evolved customer engagement model, a Health Science Associates (HSA) will engage HCPs through a variety of in-person, virtual and digital tools, offering expanded expertise regarding products and the approved conditions they treat. Otsuka's Clinical & Scientific Liaison (CSL) will provide deep clinical expertise on-demand and will engage healthcare providers to offer personalized education on disease state, thought leadership and real-world evidence. A Patient Education Liaison (PEL) works to inform, educate, and enhance the experience of patients throughout their care continuum. The HSAs are led by Ecosystem Leads and grouped into regional areas. Ecosystem Leads are led by Regional Leads with significant autonomy to assess unique market priorities and customize decisions that reflect local customer needs. In the future, Otsuka will also be shifting to a team-based approach to drive customer engagement quality, accountability, and cohesion around patients and healthcare providers. Ultimately, it is all about putting customers at the center of everything they do. **Position Overview** **- Medical** **Science Liaison** **(Senior Manager)** As an integral member of the ecosystem team for Otsuka's new ecosystem-based customer engagement model, the Medical Science Liaison (MSL), Sr Mgr contributes to the development of the ecosystem strategic business plan and identifies key stakeholders that are vital to the ecosystem. The Medical Science Liaison (MSL) is a credible partner responsible for providing clinical, scientific and health economic information related to disease states and the appropriate utilization of approved Otsuka products within an ecosystem. This field-based position will engage with Key Influencers (KIs), Local Practice Leaders (LPLs), healthcare providers, and patients' groups within their ecosystem, to further patient outcomes aligned with the overarching objectives of Otsuka. In collaboration with their ecosystem partners, CSLs contribute to the customization of the region business strategy to meet local ecosystem needs and are responsible for the medical and educational requirements of their customers. In addition, CSLs may be responsible for covering multiple products within a therapeutic area, as well as engaging in broad clinical and scientific discussions that impact patient care, resulting in rich customer insights shared within the ecosystem. **There are 2 positions available** **Key Activities and Responsibilities** + As part of the ecosystem team contributes a clinical and scientific perspective to the local execution plan that addresses ecosystem, and customer challenges, issues, and opportunities, to bring about improved patient care and outcomes. This extends to include coordination around execution of field activities. + Build, cultivate, and leverage external relationships with key scientific and medical customers and organizations within their ecosystem to ensure strong understanding of evolving healthcare trends, disease state, Otsuka products, systems, and services across the ecosystem landscape, including KIs, LPLs, Key Decision Makers (KDMs) and Patient Advocacy. + Maintain a comprehensive understanding of the ecosystem to ensure alignment with Otsuka's patient-centric strategy and priorities, including provision and delivery of optimal patient care. + To be a credible source of evidence-based information that demonstrates the value of Otsuka and its products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers, and other key stakeholders to apply practical real-world solutions to improve patient outcomes. + Build and cultivate important internal working relationships across the matrix team to ensure an enterprise approach when working with customers. Be accountable to regional Field Medical Affairs leadership to shape and execute on local medical strategies within planned timelines. + Actively contribute to planning, content development, and dissemination of disease state information to customers in the field on a regular basis using the remote customer engagement platform. + Disseminate disease state and healthcare landscape information to customers in the field on a regular basis utilizing remote customer engagement platform. + Responsible for delivering the training and evaluation of promotional and disease state speakers. + Serve as part of Otsuka's internal speaker bureau in support of product educational needs across the ecosystem. + Collect and submit medical insights that drive decision making and prioritization of evidence generation efforts and healthcare solutions, including sharing at the local ecosystem level. + Assist with Otsuka's clinical trials program, including registrational, post-marketing and Investigator-Sponsored Trials (ISTs), health economic outcomes research, other specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance. + Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. **Qualifications** + Advanced degree in Pharmacy, Medicine, Biological Sciences, Health Services Research or Public Health, (PharmD., M.D., PhD. or D.Ph.) is required. + Relevant therapeutic area knowledge is required. + Understanding of the interconnectivity of health systems, overall delivery of patient care and experience working with healthcare professionals and other decision makers. + Minimum of 3-5 years related work experience (clinical, health system or industry) + Outstanding business acumen; knows the industry, Otsuka's business model and value proposition, key competitors, and other marketplace factors/dynamics. Able to identify solutions with the overall goal of improved patient outcomes. + Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills: proven ability to achieve conflict resolution effectively and quickly with affected parties and work in a cross-functional environment. + Knows how to summarize and communicate complex information and business objectives in a concise and effective way during presentations and other interactions. + Understanding of industry legal, regulatory, and compliance landscape + Ability to work in an ambiguous environment undergoing transformation. + Demonstrates behaviors aligned with the Otsuka Corporate Brand including Perseverance, Unconventional Thinking, and Humility. + Business travel, by air or car, up to 70% of time depending upon size of ecosystem. + Preferred living location is key city in ecosystem. **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.
    $147k yearly 45d ago
  • Director, Global Quality GMP Processes

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Denver, CO job

    The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global quality processes** across the organization. This role ensures that product quality systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement** across all regions and product lines. The Director will lead global initiatives to harmonize and enhance processes related to **product quality complaints, deviations, CAPA, and management reporting** , ensuring timely and effective resolution and robust compliance. **Key Responsibilities** + Global Process Ownership: Lead the design, implementation, and continuous improvement of global quality processes for: + Product Quality Complaints + Corrective and Preventive Actions (CAPA) + Deviations + Management Reporting and Trending + Benchmarking & Best Practices: Evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (e.g., FDA, EMA, PMDA) and align with current GMP standards. + Governance & Standardization: Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all manufacturing sites and affiliates. + Quality Systems Leadership: Oversee the global deployment and optimization of electronic quality systems (e.g., TrackWise), including configuration, training, and validation. + Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies. + Data-Driven Insights: In collaboration with Quality Operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making. + Team Leadership: Build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence. **Qualifications** Required **Required Qualifications:** + Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred. + Minimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role. + Deep understanding of GMP regulations and global regulatory requirements (e.g., 21 CFR Parts 210, 211, 820). + Proven experience in managing global quality systems and optimizing complaint, CAPA, and deviation processes. + Strong analytical and problem-solving skills with a data-driven mindset. + Excellent communication, leadership, and stakeholder management skills. + Proficiency in quality management systems (e.g., TrackWise) and Microsoft Office tools. + Ability to travel internationally as needed. Preferred + Basic understanding of artificial intelligence and advanced analytics + Experience supporting risk management programs or frameworks. + Familiarity with quality management systems and digital tools. **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 $183,335.00 - Maximum $274,160.00, 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.
    $183.3k yearly 45d ago
  • Scientific/Sr Scientific Lead, Bioconjugation

    Eli Lilly and Company 4.6company rating

    Louisville, CO job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. JOB DESCRIPTION Position: Scientific/Sr Scientific Lead, Bioconjugation, Large Molecule Discovery Location: Louisville, CO, USA Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary: Lilly Oncology's Large Molecule Discovery team is looking for a Scientific Lead or Senior Scientific Lead in Chemistry/Biochemistry to support our growing biologics and ADC portfolio. This role will provide scientific leadership in developing bioconjugation technologies, downstream biochemical assays to improve ADC linker-payload design and enhance ADC biological and pharmacologic performance. The successful candidate will bring deep technical expertise in ADC design and execution, demonstrate strong experimental rigor, and act as a collaborative scientific partner across discovery teams. This position requires a hands-on scientist who can independently execute complex studies while contributing to broader platform strategy, intellectual property, and innovation. The individual will thrive in a highly interactive, fast-paced research environment and will be expected to influence project direction through high-quality data, clear scientific reasoning, and effective communication. Responsibilities: Prepare, purify, and characterize the high-quality antibody-conjugates (ADCs, ARCs, DACs etc.) with a high degree of independence in support of discovery and development of programs. Work with the linker-technology and medicinal chemistry teams to design and optimize the linker-payload and its bioconjugation chemistry. Apply organic and bioconjugation chemistry principles to guide linker-payload SAR and improve stability, potency, and developability. Implement state of the art bioconjugation technologies (cysteine, lysine, site-specific and other) and utilizing novel chemistries to generate bioconjugates. Develop purification strategies (up to 200 mg) with affinity, ion-exchange, hydrophobic interaction, size exclusion, and tangential flow filtration. Perform comprehensive ADC characterization using UV-Vis, SEC, HIC, RP-HPLC, IEX, cIEF, and LC-MS. Engage with multidisciplinary teams across chemistry, biology, pharmacology, and CMC to design and interpret experiments. Maintain thorough documentation of experimental procedures in electronic notebook or database, writing of reports and technical documents. Maintain scientific and technical expertise through familiarity with scientific literature and attending conferences. Demonstrated record of scientific accomplishments and publications. Present periodic updates and reports to management team. Contribute to the long-term strategies for innovative solutions and intellectual property for securing FTO for Lilly. Maintain a safe, pleasant, and efficient working environment. Basic Requirements: PhD in chemistry, biochemistry, or other related scientific discipline. Minimum 2-4+ years of independent, hands-on laboratory experience in an industrial or equivalent research setting (including post doc experience). Additional Preferences: Experience with protein purification systems is preferred with hands-on experience and proficiency working with AKTA FPLCs. Deep expertise in bioconjugation technologies and experience working with high-potency payloads. Proven ability to collaborate effectively with small-molecule and biologics project teams to drive rapid scientific progress. Track record of scientific accomplishment, including publications, patents, or significant internal contributions. Excellent written and verbal communication skills, with the ability to clearly convey complex scientific concepts. Attention to detail, and ability to manage multiple priorities in a dynamic environment. Self-motivated, enthusiastic, and continuously focused on improving scientific rigor, efficiency, and impact. Additional Information: Physical Demands/Travel: The physical demands of this job are consistent with a laboratory/bench environment. Some light lifting, and maneuvering may be required. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $138,000 - $224,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $138k-224.4k yearly Auto-Apply 9d ago
  • Quality Control Technician

    STAQ Pharma Inc. 3.7company rating

    Denver, CO job

    Job Description The job of the Quality Control Technician is to ensure compliance with cGMP requirements and company procedures while providing support to the QC team and throughout the QA and Operations departments. Additionally, this role is responsible for coordinating QC sample preparation and external laboratory shipments in relation to Environmental Monitoring activities and other required sampling. This role will work closely with the Production team and report quality data to department management, as needed. Duties/Responsibilities: Maintain retention materials and disposal when required. Assist with review and release of raw materials, API, excipients, and sterile supplies. Coordination of Biohazard waste destruction. Perform sampling and inspection of in-process and finished products. Assists with Environmental Monitoring and microbiological sample evaluation activities. Coordination of submitting samples for testing with third party vendors on their respective web portals or paper submissions. Logbook and controlled document generation. Assist with investigations and develop and implement corrective and preventive actions geared toward continuous process improvements. Review GMP documents including production environmental monitoring forms, room and equipment logs, etc. Support quality management system activities including document control and training program management. Other duties and tasks, as assigned. Required Skills/Abilities: Excellent independent judgement, written communication, verbal communication, and interpersonal skills. Strong attention to detail. Familiarity with Good Manufacturing Practices and FDA Regulations. Proficient in using Microsoft Word, Excel, PowerPoint, Outlook. Education and Experience: 1-3 Years as a Quality Control Technician Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing. Associate degree in the sciences or equivalent experience preferred. Physical Requirements: Ability to work in a clean room setting Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times. 7:00 am to 3:30 pm, Monday through Friday
    $37k-48k yearly est. 21d ago
  • Director, Medical Publications - Neph & Immuno

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Denver, CO job

    The Director, Nephrology & Immunology Publications Lead is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the Nephrology and Immunology therapeutic area. This role ensures the timely, accurate, and compliant communication of scientific and clinical data through congress abstracts, posters, manuscripts, and other peer-reviewed outputs. Serving as the functional lead for publication operations within the Nephrology & Immunology Medical Communications team, the Director partners closely with cross-functional stakeholders, including Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Medical Strategy, Core Content, and external vendors, ensuring excellence and consistency in scientific communication across the portfolio. The position reports to the Senior Director, Nephrology & Immunology Medical Communications Lead and plays a key leadership role in advancing Otsuka's mission to deliver impactful, evidence-based science that improves patient outcomes. **** **Key Responsibilities Include:** **Publications Strategy and Execution** + Lead execution of the publication plans for Nephrology and Immunology assets, ensuring strategic alignment with global medical objectives, data dissemination priorities, and the product lifecycle + Partner with Medical Communications and cross-functional teams to define publication timelines, data priorities, and congress/journal strategies in collaboration with study teams and medical leaders + Oversee the end-to-end development of publication deliverables, including abstracts, posters, and manuscripts to ensure scientific accuracy, quality, and adherence to Good Publication Practices (GPP), ICMJE, and company SOPs + Support the integration of publication insights into broader scientific communication platforms (SCPs), ensuring consistency across core content, field materials, and other medical channels **Vendor & Budget Management** + Manage publication vendors and medical writing partners to ensure timely delivery, cost-effectiveness + Oversee operational management of external publication agencies, providing clear direction, review, and feedback to ensure alignment with scientific and compliance standards + Manage assigned publication budgets, including forecasting, tracking, and reconciliation + Ensure efficient resource utilization and drive continuous process improvement across publication workflows **Cross-functional Leadership** + Collaborate closely with Clinical Development, Global Integrated Evidence & Innovation, Medical Strategy, and Core Content teams to ensure data readiness, accurate interpretation, and timely publication of key clinical results + Serve as a publications subject matter expert within the Nephrology & Immunology Medical Communications function, providing strategic and operational guidance to internal stakeholders and vendors + Partner with Field Medical and Medical Information to ensure consistency of published data messaging across medical channels and external communications + Contribute to integrated medical communication planning, ensuring that publications effectively support data dissemination goals and launch readiness activities + Consider technology and AI to support workflow improvement **Compliance & Quality Oversight** + Ensure all publication activities are conducted in accordance with internal SOPs, GPP, ICMJE, and regional/global regulatory requirements + Partner with Legal, Regulatory, and Compliance teams to uphold publication governance, authorship transparency, and ethical data sharing standards + Contribute to audit readiness and documentation best practices for publication records and approvals **Qualifications** **Education and Experience:** + Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) required + 10+ years of experience in Medical Affairs, Medical Communications, or Publications within the pharmaceutical or biotechnology industry + Minimum 3-5 years of experience leading publication planning and execution for global or regional programs, preferably in Nephrology, Immunology, or related therapeutic areas + Proven experience managing vendors and external medical writers, including budget oversight and performance evaluation + Strong understanding of Good Publication Practices (GPP), ICMJE guidelines, and industry standards for scientific and medical communication **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Demonstrated ability to lead publication strategy execution across global and regional teams + Exceptional project management and organizational skills, with the ability to manage multiple concurrent publication deliverables + Excellent written and verbal communication skills, with meticulous attention to scientific accuracy and compliance + Strong cross-functional collaboration skills, with the ability to influence and align internal and external partners + Proven leadership in vendor management, process optimization, and publication operations + Financial acumen and experience managing publication budgets + Strategic thinker with operational excellence mindset and the ability to translate complex data into clear, evidence-based scientific narratives **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 $205,368.00 - Maximum $307,050.00, 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.
    $205.4k yearly 45d ago
  • Inventory Specialist

    Knipper 4.5company rating

    Durango, CO job

    THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.
    $29k-38k yearly est. Auto-Apply 60d+ ago
  • Formulation Technician I

    STAQ Pharma Inc. 3.7company rating

    Denver, CO job

    This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including overtime and/or weekends, may be required. Hours of Work: Tuesday to Friday, 3 PM to 1:30 AM Safety and Responsibilities SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for filling operations. Responsible for acquiring and maintaining classified area gowning qualification. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Values and Behaviors Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. Required Qualifications and Education High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Preferred Skills Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability.
    $38k-46k yearly est. 3d ago
  • Fulfillment Manager

    STAQ Pharma Inc. 3.7company rating

    Denver, CO job

    Job Description This a critical position that involves understanding the sales process start to finish. This individual will act as a bridge supporting the sales team as their main point of contact with the operations team, assisting with onboarding customers, placing orders and troubleshooting as needed. It is required that purchased products and materials are accepted, logged, and shipped daily. Good organization and attention to detail will be required by this role. Strong IT skills are a must. In addition to order fulfillment responsibilities, this person will be responsible for general oversight of warehouse and material handling operations and staff. Responsibilities: Safely handles chemicals, corrosives, solvents, and other pharmaceutical compounds Ensures compliance with regulatory agencies such as OSHA, EPA, RCRA and company Guidelines Demonstrate physical ability to lift up to 50 pounds and push/pull pallets, product cans, etc. multiple times per shift. Demonstrates ability to stand and walk for extended periods of time. Must have patience and attention to detail when doing repetitive tasks, like labeling, prepping inventory, shipping products, etc. Keeps warehouse area clean and organized Processes and fulfills orders Coordinates customer order shipments responsible for “picking” and prepping inventory from storage for upcoming production needs that are communicated from the operations team. Takes weekly and monthly inventory, ensures accuracy VALUES & BEHAVIORS Demonstrates Innovation abilities by identifying and speaking up about possible improvements and identifying more efficient ways of doing things. Operates with Integrity by maintaining high ethical standards, cares, shows trust and respect with all employees Collaborates to create or participate effectively on diverse and high performing teams, is open to new ideas and perspectives, communicates across shifts, and demonstrates a safe work environment Demonstrates a passion to Perform by meeting personal and departmental goals, gains knowledge to display increasing independence, instills confidence in ability to perform required tasks, and progresses on qualifications within reasonable timelines Demonstrates Courage by speaking up, accepts constructive feedback, and takes accountability for mistakes and make necessary corrections Required Skills/Abilities: (examples) Must be a team player and effectively collaborate with internal departments. Excellent attention to detail. Experience in a highly regulated manufacturing industry Demonstrated willingness to take on job duties not originally assigned in order to help others at the company Education and Experience: High School Diploma or GED Required / College Degree Preferred Minimum of 2 year of continuous work experience in customer service, warehouse and/or other fulfillment related experience Microsoft Excel skills required UPS/FedEx Shipping ERP System experience preferred Salesforce Experience preferred Experience in Sales, CGMP, Pharmaceutical, customer service, and 503B Outsourcing would be a plus. Batchmaster and MDS (Systems House) experience a plus Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.
    $86k-124k yearly est. 17d ago
  • Associate Analytical Scientist I (QC)

    Cambrex 4.4company rating

    Longmont, CO job

    Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview Quality control chemist capable of executing analytical methods and provide general analytical support. Able to organize routine work with supervision and evaluate and interpret generated data. Exercise judgment within defined procedures and practices to determine appropriate action. Responsibilities Maintain working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks. Responsible for ensuring compliance with cGMP and other regulatory guidelines. Perform assigned tasks carefully, safely, and on schedule according to SOPs and supervisor instructions. Perform calibrations and verifications of instrumentation according to procedures with little to no supervision. Execute analytical methods for release and stability monitoring of bulk drug substances and drug products under cGMP requirements. Generate hand-written records of actions accurately and legibly on appropriate documentation with minimal errors. Compile, maintain, interpret and extrapolate results of analysis and communicate these results to supervisor. Utilize Laboratory Information Management System (LIMS) according to procedure for inventory management and data entry. Participate in group and project meetings as required. Maintain a clean and safe workspace. Maintain laboratory equipment and testing supplies as directed. Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems. Attend and apply new training as required. Participate in and comply with all current safety, health and environmental programs. Communicate issues or challenges to senior staff and/or laboratory management and shares ideas of process improvements. May review basic test data acquired by others and document witness of others' activities. Performs other related duties as assigned. Qualifications/Skills Some experience in science-related laboratory setting with understanding of safe chemical handling practices. Basic analytical chemistry-related laboratory technique (college level) and some understanding with simple chemistry-related experimental design. Perform common analytical test methods required (pH, simple assay, physical characterizations, etc. ) with some guidance. Ability to accurately and consistently perform simple calculations as directed and effortlessly perform common unit conversions without instruction. Early practical industry exposure to cross functional technical departments. Demonstrates understanding of the purpose and principles of cGMP and follows cGMP procedures with few errors requiring rework. Ability to use and understand some common analytical instruments according to laboratory procedures. Good oral and written communication skills. Demonstrates good ability to receive and apply feedback for performance improvement. Demonstrates ability to solicit guidance when appropriate to improve performance. May support peer-led laboratory investigations with manager support. Demonstrates ability to handle testing and other assignments within reasonable timeframes as expected by peers and management. Demonstrates ability to share ideas with peers. Basic understanding of safe handling of chemicals. Basic understanding of general laboratory techniques and simple chemistry reactions. Ability to record simple data and information legibly and accurately on technical documents including logbooks, forms, and laboratory notebooks with minimal errors. Perform simple technical review of data recorded by peers on logbooks, forms, and laboratory notebooks and identify mistakes. Ability to initiate quality events with direct supervision. Strives to engage in group/team improvement projects. Able to understand the importance of Cambrex initiatives. Ability to operate laboratory equipment and computers. Good written and verbal communication skills Education, Experience & Licensing Requirements BS in chemistry, biochemistry, microbiology, or similar science-related field and 0+ years industry experience. The hiring range in Colorado for this position is $56,900/year - $63,700/year; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-SK1 Supervision Received: Works under limited supervision. Physical Demands, Work Environment, and Travel Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required. Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. Travel: Little to no expected travel time. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-SK1BS in chemistry, biochemistry, microbiology, or similar science-related field and 0+ years industry experience. The hiring range in Colorado for this position is $56,900/year - $63,700/year; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-SK1Maintain working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks. Responsible for ensuring compliance with cGMP and other regulatory guidelines. Perform assigned tasks carefully, safely, and on schedule according to SOPs and supervisor instructions. Perform calibrations and verifications of instrumentation according to procedures with little to no supervision. Execute analytical methods for release and stability monitoring of bulk drug substances and drug products under cGMP requirements. Generate hand-written records of actions accurately and legibly on appropriate documentation with minimal errors. Compile, maintain, interpret and extrapolate results of analysis and communicate these results to supervisor. Utilize Laboratory Information Management System (LIMS) according to procedure for inventory management and data entry. Participate in group and project meetings as required. Maintain a clean and safe workspace. Maintain laboratory equipment and testing supplies as directed. Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems. Attend and apply new training as required. Participate in and comply with all current safety, health and environmental programs. Communicate issues or challenges to senior staff and/or laboratory management and shares ideas of process improvements. May review basic test data acquired by others and document witness of others' activities. Performs other related duties as assigned.
    $56.9k-63.7k yearly Auto-Apply 23d ago
  • Senior Clinical Research Project Coordinator - Denver

    Medpace 4.5company rating

    Denver, CO job

    Medpace is a leading CRO for Biotech companies and we are currently seeking a full-time, office-based Project Coordinator to join our Clinical Trial Management team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. Our therapeutic areas of focus include Oncology/Hematology, Cardiovascular/Metabolic/Renal, Infectious Disease/CNS/Ophthalmology and more. If you are looking for a fast paced, collaborative work environment in clinical research and want to develop your career even further, then this is the opportunity for you. Medpace provides Project Coordinators a 4-6 week training program that incorporates a virtual and hands on learning experience, especially for those without previous clinical research experience. Responsibilities * Engage in clinical trial management on a day to day level; * Work closely with the project CTM for timely delivery of tasks consistently with a high degree of accuracy; * Compile and maintain project-specific status reports; * Interact with the Sponsor, study sites, and internal associates; * Provide oversight and quality control of our internal regulatory filing system; * Manage study supplies; * Create and maintain project timelines; and * Coordinate project meetings and produce quality meeting minutes. Qualifications * Bachelor's degree in a health/life sciences field; * Prior experience as a Study Coordinator or within the pharmaceutical industry; and * Excellent computer (word-processing, databases, Excel, Windows), organizational, and communication skills. Compensation A target salary range of $40,000 - $85,000 with potential for bonus awards. Your compensation will be based on your skills and experience. Medpace offers the following benefits for full-time positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, pet insurance, and reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations). Applications will be accepted on an ongoing basis. For more details, please discuss with your recruiter. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Denver Perks * Denver Office Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Structured career paths with opportunities for professional growth * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * RTD Eco Pass * Secure bike storage room Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $40k-85k yearly Auto-Apply 17d ago
  • Oncology Pharmacist

    Pharmacy Careers 4.3company rating

    Colorado Springs, CO job

    Oncology Pharmacist - Advance Your Career in Cancer Care Are you a pharmacist passionate about improving the lives of patients facing cancer? We're seeking a dedicated Oncology Pharmacist to join our team and bring expertise, compassion, and precision to oncology treatment. This is your chance to contribute to groundbreaking therapies, collaborate with leading healthcare professionals, and play a vital role in supporting patients throughout their cancer journey. Key Responsibilities Review, prepare, and verify chemotherapy and targeted therapy orders for accuracy, safety, and compliance. Provide medication counseling to patients and families, helping them understand complex treatment regimens, side effects, and adherence strategies. Collaborate with oncologists, nurses, and multidisciplinary teams to optimize treatment plans and improve outcomes. Monitor patient responses to therapy, adjust recommendations, and prevent adverse drug events. Stay current with oncology drug developments, clinical guidelines, and emerging therapies. What You'll Bring Education: Doctor of Pharmacy (PharmD) or equivalent degree. Licensure: Active and unrestricted pharmacist license (Board Certification in Oncology Pharmacy [BCOP] preferred but not required). Experience: Prior experience in oncology, hematology, or hospital pharmacy preferred. New graduates with a strong interest in oncology are encouraged to apply. Skills: Exceptional attention to detail, strong communication skills, and a patient-centered mindset. Why This Role? Work at the forefront of oncology pharmacy and make a tangible impact on patient survival and quality of life. Access professional development opportunities including oncology certification support. Competitive salary, comprehensive benefits, and flexible scheduling options. Join a supportive team environment where your expertise is valued. About Us We are a healthcare organization committed to excellence in oncology care. Our oncology pharmacists play a vital role in treatment success by ensuring therapies are safe, effective, and personalized to each patient. With a strong focus on collaboration, innovation, and compassion, we empower our pharmacy team to make a meaningful difference. Ready to Make an Impact in Oncology? If you're ready to grow your career and help patients in their fight against cancer, apply today for our Oncology Pharmacist job opening. Take the next step in becoming a leader in oncology pharmacy practice.
    $78k-98k yearly est. 60d+ ago

Learn more about AGC Biologics jobs

Most common locations at AGC Biologics