... Biotechnology * Eight years of increasing responsibility in a pharmaceutical company, contract ... Experience with late-stage CMC drug development and commercialization activities * Project ...
... Biotechnology * Eight years of increasing responsibility in a pharmaceutical company, contract ... Experience with late-stage CMC drug development and commercialization activities * Project ...
... Biotechnology * Eight years of increasing responsibility in a pharmaceutical company, contract ... Experience with late-stage CMC drug development and commercialization activities * Project ...
Quick apply
... Biotechnology * Eight years of increasing responsibility in a pharmaceutical company, contract ... Experience with late-stage CMC drug development and commercialization activities * Project ...
... Biotechnology * Eight years of increasing responsibility in a pharmaceutical company, contract ... Experience with late-stage CMC drug development and commercialization activities * Project ...
Quick apply
... Biotechnology * Eight years of increasing responsibility in a pharmaceutical company, contract ... Experience with late-stage CMC drug development and commercialization activities * Project ...
... Biotechnology * Eight years of increasing responsibility in a pharmaceutical company, contract ... Experience with late-stage CMC drug development and commercialization activities * Project ...
... Biotechnology * Eight years of increasing responsibility in a pharmaceutical company, contract ... Experience with late-stage CMC drug development and commercialization activities * Project ...
Cmc In Biotech information
How is CMC used in pharmaceuticals?
In the context of CMC (Chemistry, Manufacturing, and Controls) in biotech jobs, CMC involves developing and controlling the processes for producing pharmaceuticals, ensuring product quality, safety, and efficacy. It includes activities like formulation development, process validation, and stability testing, often requiring knowledge of regulatory requirements and laboratory skills.
What is the difference between Cmc In Biotech vs Formulation Scientist?
| Aspect | Cmc In Biotech | Formulation Scientist |
|---|---|---|
| Required Credentials | Bachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledge | Bachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience |
| Work Environment | Laboratories, manufacturing facilities, regulatory settings | Laboratories, R&D departments, manufacturing units |
| Employer & Industry Usage | Biotech companies, pharmaceutical firms, contract manufacturing organizations | Pharmaceutical companies, biotech firms, contract labs |
While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.
What is a CMC in biotech?
In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing and producing a pharmaceutical product. CMC professionals ensure that drugs are manufactured consistently, meet quality standards, and comply with regulatory requirements, often working with laboratory techniques, quality assurance, and regulatory submissions.
What is the highest paying job in biotech?
In biotech, senior executive roles such as Chief Scientific Officer (CSO) or Vice President of Research typically have the highest salaries, often exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and leadership skills in research and development environments.
What are CMC jobs?
CMC jobs in biotech refer to roles involved in Chemistry, Manufacturing, and Controls activities, which ensure the quality, safety, and efficacy of biopharmaceutical products. These positions often require knowledge of regulatory requirements, laboratory skills, and experience with process development and validation. CMC professionals play a critical role in drug development and manufacturing compliance.
What are popular job titles related to Cmc In Biotech jobs in Wisconsin? For Cmc In Biotech jobs in Wisconsin, the most frequently searched job titles are:
What job categories do people searching Cmc In Biotech jobs in Wisconsin look for? The top searched job categories for Cmc In Biotech jobs in Wisconsin are:
Full-time
PTO
Posted 5 days ago
Job description
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Group Manager, PDO is a member of a team charged with ownership of end-to-end alignment of Arrowhead products from preclinical through commercial phases. This role is accountable for assigned projects and provides leadership to cross-functional CMC teams from drug substance process development through delivery of clinical kits. This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is responsible for mentoring, performance management, and team development. In addition, this individual is partner-facing, serving as a key point of contact for stakeholders and external partners. The role will manage external relationships, including partnerships, and act as the primary contact for contract manufacturing organizations (CMOs) and contract research organizations (CROs) supporting development, analysis, manufacturing, packaging, and labeling activities for Arrowhead drug development programs.
Responsibilities
Requirements
Preferred
Wisconsin pay range
$125,000-$135,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
California Applicant Privacy Policy
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Group Manager, PDO is a member of a team charged with ownership of end-to-end alignment of Arrowhead products from preclinical through commercial phases. This role is accountable for assigned projects and provides leadership to cross-functional CMC teams from drug substance process development through delivery of clinical kits. This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is responsible for mentoring, performance management, and team development. In addition, this individual is partner-facing, serving as a key point of contact for stakeholders and external partners. The role will manage external relationships, including partnerships, and act as the primary contact for contract manufacturing organizations (CMOs) and contract research organizations (CROs) supporting development, analysis, manufacturing, packaging, and labeling activities for Arrowhead drug development programs.
Responsibilities
- Act as primary point of contact for projects, facilitating communication between internal and external team members for CMC development, analytical, manufacturing, packaging, and labeling activities with minimal support of direct management
- Maintain a clear understanding of project status and tailor communications appropriately for Arrowhead leadership, relevant stakeholders, and partner companies
- Manage budget, timeline, quality and deliverables for each project and vendor
- Escalate risks, drive scenario planning, and present recommendations to leadership teams
- Maintain and expand upon current project tracking tools (ex. Smartsheet, Excel, Power BI)
- Analyze project metrics and prepare recommendations for leadership
- Interface with cross-functional project team (Chemistry, Engineering, Analytical, Quality) on partner development and manufacturing activities
- Track, manage, and negotiate new proposals and draft RFPs with support from technical SME's and Legal
- Steer alignment among technical SME's, Sourcing & Supplier Management, Legal, and Finance on contracts, supply agreements, confidentiality agreements, and purchase orders for new and existing vendors
- Track vendor invoices and collaborate with Finance to process payments
- Develop, collect, and maintain performance metrics for internal and external partners
- Lead project meetings, vendor/partner visits, and conference calls
- Facilitate internal discussions to obtain team consensus and decisions
- Drive business review meetings with vendors with support from Sourcing & Supplier Management
- Support vendor management responsibilities and activities, as needed
- Assist in developing and review CMC outsourcing budget
- Coach and mentor direct reports in the creation of personal goals, development, and performance improvement
- Generate, maintain, and approve training materials and support onboarding of new team members
- Collaborate with Alliance Management on partnership goals.
- Other duties as assigned
Requirements
- Bachelor's degree in a scientific field such as Chemistry, Chemical Engineering, Biochemistry, Biotechnology
- Eight years of increasing responsibility in a pharmaceutical company, contract manufacturing organization or contract research organization including direct report experience
- Minimum five years in a project management role with experience managing clients, partners, and/or vendors
- Knowledge of applicable GLP, GMP, and regulatory guidance for pharmaceutical manufacturing and testing
- Strong MS Office skills (Outlook, Excel, PowerPoint, and Word)
- Excellent verbal and written communication skills
- Ability to work with diverse professionals in a matrix environment
- Highly motivated team player willing to contribute to a growing biotech organization
- A detail oriented, organized, self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead
Preferred
- Master's degree in Chemistry, Chemical Engineering, Biochemistry or related science field
- GLP or GMP Laboratory or Manufacturing experience
- Experience with late-stage CMC drug development and commercialization activities
- Project Management Certification
- ERP system experience
Wisconsin pay range
$125,000-$135,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
California Applicant Privacy Policy
About Arrowhead Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
201 - 500 Employees
Headquarters location
Pasadena, CA, US
Year founded
1989