AGC Biologics
AGC Biologics
is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com . VICE PRESIDENT, PROCESS DEVELOPMENT SUMMARY: The Vice President (VP) of Process Development (PD) will be responsible for overseeing the development, commercialization and lifecycle management of biologic drug products. The VP will provide leadership to an organization responsible for Cell Line Development (CLD), Upstream Process Development (UPD), Downstream Process Development (DPD), and Analytical and Formulation Development (AFD).In addition, the VP of PD will be a member of the site senior Leadership Team, responsible for providing leadership and decision making to the Seattle site. PRINCIPAL RESPONSIBILITIES: · Provide leadership and direction to the Process Development organization, a department of 60+ scientists and engineers · Serve as an active member of the site Leadership Team responsible for development and setting of site strategy and goals · Mentor and develop staff members within the organization · Oversee development operations working on projects ranging from early phase to commercial stage biologics · Champion the development and implementation of new technologies, methodologies and systems to drive innovation in biologics development · Develop strong relationships with customers; support the creation of strategic plans with clients for the development of biologic drug candidates · Work closely with Business Development in support of acquiring new customers and partners · Drive development and implementation of new systems to improve project execution and data management · Support regulatory filings (e.g., IND, BLA, MAA) and associated product related inspections from regulatory agencies (e.g., FDA, EMA) · Provide technical support to the cGMP manufacturing operation · Develop and manage department budget KNOWLEDGE, SKILLS & ABILITIES: · Staff Leadership.
Translates mission, vision, values into actionable goals and objectives. Provides adequate structure, direction and feedback. Creates environment where staff feel valued, respected and empowered. Shows appreciation for and rewards individual and group excellence. Demonstrates high standards of ethics and fairness. Takes appropriate risks and encourages staff to do the same. Works through conflict and insures productive resolution. Maintains confidentiality of private and sensitive information. · Job Knowledge and Skills.
Possesses required knowledge and skills to successfully perform job. Rapidly embraces and applies new ideas and approaches where doing so adds value. · Results Orientation.
Knows how to get things done in an effective and efficient manner with available resources. Plans and prioritizes work, sets and accomplishes goals, and completes quality work on schedule. Maintains a sense or urgency in accomplishing work. Strives to improve company and individual performance. · Leadership.
Takes personal responsibility, leads by example and conscientious. Demonstrates initiative and is committed to and enthusiastic about achieving company success. · Decision Making.
Makes timely and sound decisions based on a combination of analysis, experience and judgment. Consults others, as appropriate. Understands and takes into consideration how decisions impact others . · Customer Focus/Team Work.
Develops and maintains adequate customer satisfaction levels with internal and external audiences. Demonstrates a bias toward service, quality and teamwork. Builds constructive and effective working relationships. Is committed to the success of all stakeholders. · Communication . Cultivates a culture of openness and information sharing. Demonstrates integrity and honesty in all communication. Is willing to “speak the truth” and advocate positions even when unpopular. Provides constructive feedback. Assumes ownership and accountability. EDUCATION / EXPERIENCE: ·B.S. in science or engineering, or related field ·preference for Ph.D. in science or engineering · 15+ years of experience in biopharmaceutical development with a strong background in biologics product development and 5+ years in a leadership role · Experience and understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics · Experience supporting regulatory filings (e.g., IND, BLA, MAA) and supporting product-related inspections for US and foreign regulatory agencies · Experience developing, implementing and executing strategic plans and objectives for organizations and departments COMPENSATION RANGE: $229,000 - $315,000 Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities. Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave. Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance. AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. About the company
AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), with a commitment to completing projects right, and on time. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com . VICE PRESIDENT, PROCESS DEVELOPMENT SUMMARY: The Vice President (VP) of Process Development (PD) will be responsible for overseeing the development, commercialization and lifecycle management of biologic drug products. The VP will provide leadership to an organization responsible for Cell Line Development (CLD), Upstream Process Development (UPD), Downstream Process Development (DPD), and Analytical and Formulation Development (AFD).In addition, the VP of PD will be a member of the site senior Leadership Team, responsible for providing leadership and decision making to the Seattle site. PRINCIPAL RESPONSIBILITIES: · Provide leadership and direction to the Process Development organization, a department of 60+ scientists and engineers · Serve as an active member of the site Leadership Team responsible for development and setting of site strategy and goals · Mentor and develop staff members within the organization · Oversee development operations working on projects ranging from early phase to commercial stage biologics · Champion the development and implementation of new technologies, methodologies and systems to drive innovation in biologics development · Develop strong relationships with customers; support the creation of strategic plans with clients for the development of biologic drug candidates · Work closely with Business Development in support of acquiring new customers and partners · Drive development and implementation of new systems to improve project execution and data management · Support regulatory filings (e.g., IND, BLA, MAA) and associated product related inspections from regulatory agencies (e.g., FDA, EMA) · Provide technical support to the cGMP manufacturing operation · Develop and manage department budget KNOWLEDGE, SKILLS & ABILITIES: · Staff Leadership.
Translates mission, vision, values into actionable goals and objectives. Provides adequate structure, direction and feedback. Creates environment where staff feel valued, respected and empowered. Shows appreciation for and rewards individual and group excellence. Demonstrates high standards of ethics and fairness. Takes appropriate risks and encourages staff to do the same. Works through conflict and insures productive resolution. Maintains confidentiality of private and sensitive information. · Job Knowledge and Skills.
Possesses required knowledge and skills to successfully perform job. Rapidly embraces and applies new ideas and approaches where doing so adds value. · Results Orientation.
Knows how to get things done in an effective and efficient manner with available resources. Plans and prioritizes work, sets and accomplishes goals, and completes quality work on schedule. Maintains a sense or urgency in accomplishing work. Strives to improve company and individual performance. · Leadership.
Takes personal responsibility, leads by example and conscientious. Demonstrates initiative and is committed to and enthusiastic about achieving company success. · Decision Making.
Makes timely and sound decisions based on a combination of analysis, experience and judgment. Consults others, as appropriate. Understands and takes into consideration how decisions impact others . · Customer Focus/Team Work.
Develops and maintains adequate customer satisfaction levels with internal and external audiences. Demonstrates a bias toward service, quality and teamwork. Builds constructive and effective working relationships. Is committed to the success of all stakeholders. · Communication . Cultivates a culture of openness and information sharing. Demonstrates integrity and honesty in all communication. Is willing to “speak the truth” and advocate positions even when unpopular. Provides constructive feedback. Assumes ownership and accountability. EDUCATION / EXPERIENCE: ·B.S. in science or engineering, or related field ·preference for Ph.D. in science or engineering · 15+ years of experience in biopharmaceutical development with a strong background in biologics product development and 5+ years in a leadership role · Experience and understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics · Experience supporting regulatory filings (e.g., IND, BLA, MAA) and supporting product-related inspections for US and foreign regulatory agencies · Experience developing, implementing and executing strategic plans and objectives for organizations and departments COMPENSATION RANGE: $229,000 - $315,000 Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities. Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave. Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance. AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. About the company
AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), with a commitment to completing projects right, and on time. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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