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Industry: Zeitungsverlage
Company Size: 201–500 Beschäftigte

CHEManager International

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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**

Arrowhead is seeking a motivated process development scientist to join our Chemistry Manufacturing and Controls group focusing on formulation and drug product. The successful candidate will be tasked with managing external drug product manufacturing and developing drug product formulations.

**Responsibilities**

- Provide technical direction to Contract Development and Manufacturing Organizations (CDMO) for external Drug Product operations

- Develop formulations of oligonucleotide and oligonucleotide-conjugate drug products appropriate for the phase of pharmaceutical development

- Characterize drug product formulations to support clinical dosing and regulatory filings

- Review and approve batch records for use at CDMOs

- Author and execute formulation characterization protocols and author technical reports

- Draft and review technical documentation and leverage expertise to support regulatory filings

- Present data and technical information to intra- and inter-departmental colleagues and management

- Maintain a well-documented laboratory notebook.

- Track project deliverables and provide updates on progress to team members, management, and cross-functional teams.

- Coordinate delivery of materials both internally and externally

**Requirements**

- M.S. with at least 5+ years or B.S. with at least 7+ years of relevant industrial academic experience

- Experience with formulation development or drug product manufacturing.

- Excellent analytical, critical thinking, and communication skills

- Proactive, solutions-oriented mindset to anticipate challenges and devise solutions

- Understanding of the drug development process and governing regulations.

- Familiarity with cGMP and FDA/EMA requirements

**Preferred**

- Direct experience overseeing CDMOs and external partners

- Formulation development experience

- Experience authoring regulatory CMC sections for regulatory filings

- Knowledge of FDA and ICH guidelines pertaining to drug product development and registration

Wisconsin pay range

$95,000-$110,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

California Applicant Privacy Policy

Scientist II, CMC Process Development

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**

This role provides clinical pharmacology and pharmacometrics leadership for assigned development programs and may be based in San Diego, CA or Madison, WI. The position is responsible for contributing to clinical trial design, authoring key protocol and regulatory sections, and performing hands-on PK/PD analyses to guide dose selection and program strategy. It oversees the preparation and authorization of PK analysis reports, CSR content, and clinical pharmacology components of global regulatory submissions

**Responsibilities**

- Provide Clinical Pharmacology and pharmacometrics leadership for designated programs, contribute to design of clinical trial protocols and relevant sections in Investigational Brochure (IB), conduct hands-on analysis of clinical or translational PKPD data, support dosing strategies and clinical pharmacology planning. Authorize clinical PK analysis reports and relevant sections in the Clinical Study Report (CSR).

- Provide high quality documentation of clinical pharmacology analysis compatible with global regulatory submission requirements. Authorize clinical pharmacology modules of CTD to support global filings of marketing application.

- Provide timely communication of analysis results and interpretation with drug development teams.

- Maintain a current understanding of clinical pharmacology literature and regulatory guidance for oligonucleotide/RNAi therapeutics

**Requirements**

- PhD or PharmD in the field of pharmacokinetics, pharmacology or pharmaceutical science,

- 3 years of pharmaceutical industry experience in clinical-stage drug development.

- Good understanding of FDA/EMA/ICH guidance related to clinical pharmacology

- Established experience in clinical NCA PK analysis and data reporting using Phoenix WinNonlin with familiarity of authorizing PK study report.

- Proficiency in NONMEM and skill of population PKPD modeling is essential.

**Preferred**

- PBPK/PD modeling

California pay range

$120,000-$170,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

California Applicant Privacy Policy

Senior Scientist / Principal Scientist, Clinical Pharmacology

Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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. Our RNAi-based therapeutics are at the leading edge of genetic-based therapy with the potential to bring life changing treatments for patients.

Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on actively targeted drug delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety.   

Our employees are nimble, science-driven, and innovative professionals.   A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics to add to our growing pipeline.     

Arrowhead’s corporate headquarters is located in Pasadena, CA. Just north of Los Angeles and resting in the foothills of the San Gabriel Mountains. Research and development activities are in Madison, WI and San Diego, CA with a newly built GMP manufacturing facility in Verona, WI. We have invested heavily in our research workspaces to make sure our top-notch scientists can continue to quickly change the world in meaningful ways.

Be aware that all job related Arrowhead communication should come from the domain @arrowheadpharma.com.

Industry: Pharmaceutical Manufacturing
Company Size: 501-1,000 employees

Arrowhead Pharmaceuticals

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 Associate Manufacturing Scientist I (second shift) role will involve assisting in the synthesis and subsequent purification steps of large scale oligonucleotides. The operator must comply with GLP/GMP protocols and be able to follow all association SOPs and work instructions when performing and documenting operations.

2nd shift work hours are 1pm – 11{{:}}30 pm Monday - Thursday and includes a 10% shift differential.

**Responsibilities **

- Follow batch records, SOPs, and work instructions to detail

- Document all operations in batch records and logbooks

- Comply with GMP protocols

- Operate large scale oligonucleotide manufacturing equipment (i.e. oligonucleotide synthesizer, purification skid, tangential flow filtration system, lyophilizer, ChemGlass reactors, pH/conductivity meters, peristaltic pumps, etc.)

- Assist other chemists within the Manufacturing group during synthesis and purification of oligonucleotides including{{:}}Reagent solution preparationMobile phase preparationColumn PackingFraction collection

- Perform oligonucleotide/intermediate analysis via LCMS

- Communicate with cross-functional groups such as Process Development, Analytical Development, Quality Control, Quality Assurance, etc.

- Maintain a clean work space

- Maintain safety by wearing required personal protective equipment

- Track and update raw material usage in D365 ERP software

- Act as production campaign lead

- Assist with new personnel training

**Requirements{{:}} **

- Bachelor's degree in a scientific field OR appropriate work experience

- Entry level to 2 years experience in a similar position

**Preferred{{:}} **

- Good verbal and written communication skills

- Ability to work in a team environment

- Ability to pay attention to detail

- Experience working in a GMP setting and controlled documentation

Wisconsin pay range {{:}} $60,000 USD - $70,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

California Applicant Privacy Policy

Associate Manufacturing Scientist I (2nd shift)

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