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WuXi AppTec Peptide Platform

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Job: Associate Director, Peptide/Oligonucleotide Analytical

Location: Wuxi City, Jiangsu Province

Hiring: 1

Overview

STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading small molecule pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), STA offers our worldwide partners efficient, flexible and high-quality solutions for small molecule Active Pharmaceutical Ingredients (APIs) and finished dosage forms.

A Leading Company of Contract Development and Manufacturing Organization(CDMO)

The World’s Largest Process Chemistry Team

To learn the most cutting edge technologies in the pharmaceutical development field

To work with 200+ global new drug development companies

Systemic and Multiple Training Programs(Technical/Soft skills/Management)

Diversified Career Development and Promotion Trails

Responsibilities

Play a leading role in the analytical method development and validation for peptide/oligonucleotide drug products utilizing a variety of analytical techniques.

Implement analytical methods for in-process testing, release and stability testing of peptide/oligonucleotide drug products.

Lead mass spec characterization of peptide/oligonucleotide drug products at various stages of development.

Design and execute experiments with a high level of independence. Analyze, interpret, and deliver results in timely fashion.

Assess in-house equipment and propose/assess outside technologies that can benefit projects.

Provide qualified technical guidance to junior staff members.

Qualifications

Ph.D. in Analytical Chemistry or related discipline with at least 5 years, or M.S. with at least 8 years or B.S. with at least 10 years of industry experience.

Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner.

Strong understanding of method development for peptides and oligonucleotides.

Experience in a wide variety of analytical techniques including liquid chromatography, mass spectrometry, UV, SEC, etc.

Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.

Strong communication skills and ability to provide cross-functional leadership and guidance.

Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents

Demonstrate a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

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Job: Associate Director Business Development Oligo/Peptide

Location:

Hiring: 1

Overview

The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for STA Pharmaceutical, a WuXi AppTec company, in particular to support the growth of emerging oligo and peptide (O&P) Contract Development and Manufacture (CDMO) business. The candidate will work closely together with the U.S. and Europe business development (BD) teams to pursue new business leads; follows up on critical issues and aides in resolving customer inquiries. Assists marketing in delivering content and driving success of new and existing services. This position will report to the Director of Business Development, Oligo/Peptide and will help to support O&P BD effort in the East Coast.  

Responsibilities:

Prospects for oligo and peptide new drug development companies who would benefit from STA’s CDMO services.

Obtains conferences and meetings to present STA services to prospective and existing clients via email, phone, and web-conferencing systems.

Acts upon, refers and follows-up on leads from both sales and marketing campaigns.

Increase awareness of STA’s marketing initiatives including scheduling meetings for tradeshows and driving registrations for webinars and seminars.

Maintains knowledge of industry trends, funding, regulatory influence, mergers and acquisitions, in-out licensing of products/technologies, government/private grants and contacts, new drug development and approvals, related patent grants and notifications, market growth of small, med, and large cap companies.

Develops a social network of industry related contacts via LinkedIn and other social networking platforms.

Strategizes quarterly business development plans and benchmarks performance for continued success.

Travel to local client meetings and tradeshows to assist Business Development team as required.

Proposes new ideas and strategies to increased performance and drive personal and team goals.

Documents information in Client Relationship Management (CRM) including: contacts, pre-screened/qualified leads, and new account information as required.

Qualifications:

BA/BS in Chemistry and certain professional training/experience in business (i.e. Marketing, Sales) or Information Science is required.

3+ year’s relevant experience working in oligo or peptide new drug development or CRO/CMO industry (Oligo preferred)

Must be a self starter, self-motivated, highly flexible, with excellent communications skills (verbal, written, and presentation skills). Must be organized and detailed-oriented.

Must have a proven track record of meeting or exceeding sales growth objectives and/or simultaneously managing several projects and timelines.

Ability to perform within a professional environment and use judgment as dictated by complexity of situation.

Experience with CRM (Customer Relationship Management) software (i.e. SalesForce and/or Microsoft Dynamics/CRM) is preferred.

Ability to accomplish the described duties through the use of appropriate computer equipment and software (i.e Microsoft Word, Excel, Outlook, PowerPoint and CRM) is required.

PREFFERED QUALIFICATIONS:

MS or PhD a plus

Knowledge of O&P chemistry

Knowledge of pharma/biotech markets and related O&P market trends

Ability to perform a full sales cycle to close deals and maintain motivation when faced with challenging situations

Demonstrate a can-do attitude

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Job: Associate Director Business Development EU, Oligos / Peptides

Location:

Hiring: 1

Overview

The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for STA Pharmaceutical, a WuXi AppTec company, in particular to support the growth of emerging oligo and peptide (O&P) Contract Development and Manufacture (CDMO) business. The candidate will work closely together with the U.S. and Europe business development (BD) teams to pursue new business leads; follows up on critical issues and aides in resolving customer inquiries. Assists marketing in delivering content and driving success of new and existing services. 

Responsibilities

Prospects for oligo and peptide new drug development companies who would benefit from STA’s CDMO services.

Obtains conferences and meetings to present STA services to prospective and existing clients via email, phone, and web-conferencing systems.

Acts upon, refers and follows-up on leads from both sales and marketing campaigns.

Increase awareness of STA’s marketing initiatives including scheduling meetings for tradeshows and driving registrations for webinars and seminars.

Maintains knowledge of industry trends, funding, regulatory influence, mergers and acquisitions, in-out licensing of products/technologies, government/private grants and contacts, new drug development and approvals, related patent grants and notifications, market growth of small, med, and large cap companies.

Develops a social network of industry related contacts via LinkedIn and other social networking platforms.

Strategizes quarterly business development plans and benchmarks performance for continued success.

Travel to local client meetings and tradeshows to assist Business Development team as required.

Proposes new ideas and strategies to increased performance and drive personal and team goals.

Documents information in Client Relationship Management (CRM) including: contacts, pre-screened/qualified leads, and new account information as required.

Qualifications:

BA/BS in Chemistry and certain professional training/experience in business (i.e. Marketing, Sales) or Information Science is required.

2+ year’s relevant experience working in oligo or peptide new drug development or CRO/CMO industry (Oligo preferred)

Must be a self-starter, self-motivated, highly flexible, with excellent communications skills (verbal, written, and presentation skills). Must be organized and detailed-oriented.

Must have a proven track record of meeting or exceeding sales growth objectives and/or simultaneously managing several projects and timelines.

Ability to perform within a professional environment and use judgment as dictated by complexity of situation.

Experience with CRM (Customer Relationship Management) software (i.e. SalesForce and/or Microsoft Dynamics/CRM) is preferred.

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Job: Director, CMC Project Management

Location:

Hiring: 1

Responsibilities

Lead all project initiation and planning efforts. Participate in the implementation and execution of a given project. Establishes project objectives, timelines and deliverables. Defines project tasks and resource requirements.

Closely monitor/control project progression to ensure project is completed on schedule and within budget. Reports project progress to all key stakeholders.

Supports the technical team to investigate any project challenges by necessary risk assessment tools & techniques, and then implements corrective measures.

Serves as liaison with client contacts, manages day-to-day communications and organizes project team meetings.

Represents company in project meetings, prepares meeting agenda and minutes, and follows up on action items.

Evaluates and assesses project results and provides recommendations for future improvements.

Provides support to the business development team joining customer visits, conferences or tradeshows.

Prepare Quotations/Proposals/Change Orders with inputs from key stakeholders for existing relationships.

Qualifications

Education and Experience:

Masters (MS) or PhD in life sciences; chemistry preferred

A minimum of 5 years pharmaceutical or CRO/CMO industry experience preferably in API process R&D and manufacturing and/or Drug Product R&D and manufacturing.

Prior experience in project management or managing external research collaborations, with PMP certification desired.

Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas.

Demonstrates good understanding of the pharmaceutical industry and small molecule drug development.

Minimum of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing.

Working knowledge and understanding of current regulations and industry trends for small molecule, Antibody-Drug Conjugate (ADC) product development, manufacture and testing. Oligonucleotide and Solid State Peptide experience a plus.

Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.

Must have working knowledge of MS Office products, especially MS Project.

Independence/Accountability:

Must be a self-starter, self-motivated, and highly flexible in this homebased position with ~25% travel.

Must be organized and detailed-oriented.

Problem Solving:

Proven experience in creating and carrying out successful plans and processes to solve complex problems. 

Leadership Activities:

Work closely with team members across all CMC related business units and with the STA management team to ensure coordination of all efforts and real-time communication with all stakeholders.  

Communication Skills:

Proficiency in both English and Mandarin is required.

Excellent communications skills (verbal, written, and presentation skills).

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Job: Project Manager (Bilingual), EU

Location:

Hiring: 1

Overview

The Project Manager will be responsible for managing projects within STA, WuXi’s API and Drug Product development and manufacturing division.  Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team.  The incumbent will also participate in business development activities such as visiting existing or new clients and promoting STA’s services in conferences/trade shows. 

Please note this is a remote (work from home) position within the EU and that English and Mandarin language skills are required. 

Responsibilities

Lead all project initiation and planning efforts. Participate in the implementation and execution of a given project.

Establishes project objectives, timelines and deliverables. Defines project tasks and resource requirements. 

Closely monitor/control project progression to ensure project is completed on schedule and within budget. Reports project progress to all key stakeholders. 

Supports the technical team to investigate any project challenges by necessary risk assessment tools & techniques, then implements corrective measures.

Serves as liaison with client contacts, manages day-to-day communications and organizes project team meetings.

Represents company in project meetings, prepares meeting agenda and minutes, and follows up on action items.

Evaluates and assesses project results and provides recommendations for future improvements.

Provides support to the business development team joining customer visits, conferences or tradeshows.

Prepare Quotations/Proposals/Change Orders with inputs from key stakeholders for existing relationships

Qualifications

Education and Experience:

Masters (MS) or PhD in life sciences; chemistry preferred

A minimum of 5 years pharmaceutical or CRO/CMO industry experience preferably in API process R&D and manufacturing and/or Drug Product R&D and manufacturing.

Prior experience in project management or managing external research collaborations, with PMP certification desired.

Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas.

Demonstrates good understanding of the pharmaceutical industry and small molecule drug development.

Minimum of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing.

Working knowledge and understanding of current regulations and industry trends for small molecule, Antibody-Drug Conjugate (ADC) product development, manufacture and testing. Oligonucleotide and Solid State Peptide experience a plus.

Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.

Must have working knowledge of MS Office products, especially MS Project.

 Independence/Accountability:

Must be a self-starter, self-motivated, and highly flexible in this homebased position with ~25% travel.

Must be organized and detailed-oriented.

Problem Solving:

Proven experience in creating and carrying out successful plans and processes to solve complex problems.

Leadership Activities:

Work closely with team members across all CMC related business units and with the STA management team to ensure coordination of all efforts and real-time communication with all stakeholders.

Communication Skills:

Proficiency in both English and Mandarin is required.

Excellent communications skills (verbal, written, and presentation skills).

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Job: Technical Operation Director, Peptide & Oligo Process Development

Location: Changzhou City, Jiangsu Province

Hiring: 1

Overview

STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading small molecule pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), STA offers our worldwide partners efficient, flexible and high-quality solutions for small molecule Active Pharmaceutical Ingredients (APIs) and finished dosage forms.

A Leading Company of Contract Development and Manufacturing Organization(CDMO)

The World’s Largest Process Chemistry Team

To learn the most cutting edge technologies in the pharmaceutical development field

To work with 200+ global new drug development companies

Systemic and Multiple Training Programs(Technical/Soft skills/Management)

Diversified Career Development and Promotion Trails

Responsibilities

Provides technical support for pilot- and commercial-scale production of intermediates and API that requires the application of innovative manufacturing technologies, especially for Oligo/Peptide SPPS, preparative chromatography (HPLC, IEX, UFDF, etc.), and lyophilization. Technical support are realized in the form of (include but are not limited to):

Design, modification and assembly of equipment and set up

Selection and evaluation of process technology and methods

Development, determination and optimization of process parameters

Devise tests before actual production, collect and analyze process data

Enabling, execution and troubleshooting of production

Serves as the subject matter expert or chief process engineer to communicate with clients and internal stakeholders to understand their technical requirements on API production. Translate such request into well-defined and practicable action items for the production team to implement. Report the production results afterwards, summarize key findings & problems, and suggest solutions for future improvement.

Keep track of the status of existing manufacturing technologies that are already applied and identify areas of deficiency. Devise plans, action items and resources for technology consolidation, debottlenecking and continuous improvement.

Explore, introduce and develop new technical capabilities and platforms based on project and market need by collaborating with R&D teams or other departments. Formulate long- term technical roadmaps to facilitate business growth and to create new source of revenue for the company.

Supervise and mentor a team of subject matter experts and process engineers to ensure all the relevant API production projects are fully supported, and to build up a pipeline of versatile talents to meet the rapid growth in the service of the company.

Manages a pool of specialized equipment and a number of laboratories and warehouses for SPPS, preparative chromatography and lyophilization. Adopt measures to maintain well-organized inventory, maximize equipment utilization rate and minimize the maintenance cost.

Establish, develop and continuously upgrade the GMP documentation systems, standard operating procedures (SOP), technical working instruction (TWI) of various manufacturing technologies to ensure the production operation are compliant with the GMP policy and to satisfy the highest safety standard.

Provides technical trainings and seminars to personnel of other departments to promote the application of new manufacturing technologies, and to resolve any misconception and miscommunication.

Qualifications

Master, or more preferably, doctoral degree in chemical engineering, pharmaceutical engineering or other relevant disciplines

5+ years research or industrial experience in pharmaceutical, chemical or other related

industries; oversea study research and working experience is definitely an advantage

Familiar with Oligo/Peptide API manufacturing process and/or common chemical unit operations

Solid knowledge or experience in Oligo/Peptide chemistry, preparative chromatography and /or lyophilization is an advantage

Familiar with GMP operation is preferred

Good oral and written communication skill in English and Mandarin is a must

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