Associate Director, Engineering
MSD Malaysia, Phila, PA, United States
**Job Description**Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough.Seeking a candidate for a leadership position in our Research & Development Division’s Biologics Pilot Plant (BPP) Process Operations Team.
We are recruiting a highly motivated and experienced person to lead teams of process engineers in Bioprocess Clinical Manufacturing and Technology. This role will focus on two main elements: 1) Managing portions of on the floor manufacturing of large molecule clinical drug substance campaigns, inclusive of vaccines and biologics and 2) Managing overall program timelines for large molecule clinical drug substance campaigns coming in and out of the pilot plant. The ideal candidate will drive operational excellence, ensuring right-first-time (RFT) batch execution on the manufacturing floor, while providing technical oversight for operators. This will be balanced with ability to manage long end to end timelines and drive to drug substance deliverables for preparation, execution, and closeout of work. This position is based on-site, in a fast-paced and dynamic setting, requiring adaptability and quick thinking.In this position, you will exemplify our Company's leadership qualities by demonstrating integrity in all interactions, fostering a culture of innovation by encouraging creative solutions within your team, and embracing collaboration across functions to achieve common goals. You will hold yourself and your team accountable for delivering results, while also considering the long-term impacts of your decisions on our community and the environment. Additionally, you will champion diversity and inclusion by building a well-rounded team of subject matter experts, ensuring multiple perspectives contribute to our manufacturing processes.**Key Responsibilities**:* Manage and mentor a team of process engineers specializing in bioprocess manufacturing for large molecules (vaccines and biologics).* Drive operational excellence for right-first-time (RFT) batch execution on the manufacturing floor.* Collaborate with cross-functional teams to ensure agile pipeline deliverables are met* Manage end to end timelines of clinical campaigns coming in and out of the pilot plant through preparation, execution, and close out**Education Minimum Requirement:**Bachelor's degree or Master's degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry.**Required Experience and Skills**:* A highly motivated individual with the ability to work in a fast-paced and dynamic environment* Demonstrated ability to mentor team members and influence cross-functional groups* Technical knowledge of fermentation and cell culture processes, including aseptic techniques, live virus handling, BSL2 practices, cleanroom protocols, and/or bioprocessing equipment* Technical knowledge in purification processes such as chromatography, tangential flow filtration (TFF), and/or dead-end filtration* Knowledge of the considerations required for transitioning from development to GMP (Good Manufacturing Practice) environments and influencing necessary adaptations* Strong understanding of cGMP (current Good Manufacturing Practices), quality systems, and safety protocols within operations* Hands on bioprocess experience either through labs or operations* Previous experience in leading projects in either process development or GMP environments**Preferred Experience and Skills**:* Excellent organizational and problem-solving abilities* Capability to work both independently and collaboratively, delivering strong results* Exceptional conflict management and negotiation skills* Strong communication skills paired with personnel development aptitude* Prior management experience, or experience leading teams* Experience with SAP inventory management system and/or SAP QN* Demonstration of Decision Making, Execution Excellence, Innovation, and Change Catalyst Leadership Skills**Required Skills:**Adaptability, Biopharmaceutical Industry, Cell Cultures, Chemical Engineering, Data-Driven Decision Making, Fast-Paced Environments, Good Manufacturing Practices (GMP), Mammalian Cell Culture, Manufacturing, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence, Process Optimization, Safety Compliance, Safety Protocols, SAP Inventory Management, Strategic Thinking, Tangential Flow Filtration (TFF), Technical Mentoring, Technical Writing**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**US and Puerto Rico Residents Only:**Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please
if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.**U.S. Hybrid Work Model**Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The salary range for this role is$142,400.00 - $224,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.
Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available #J-18808-Ljbffr
We are recruiting a highly motivated and experienced person to lead teams of process engineers in Bioprocess Clinical Manufacturing and Technology. This role will focus on two main elements: 1) Managing portions of on the floor manufacturing of large molecule clinical drug substance campaigns, inclusive of vaccines and biologics and 2) Managing overall program timelines for large molecule clinical drug substance campaigns coming in and out of the pilot plant. The ideal candidate will drive operational excellence, ensuring right-first-time (RFT) batch execution on the manufacturing floor, while providing technical oversight for operators. This will be balanced with ability to manage long end to end timelines and drive to drug substance deliverables for preparation, execution, and closeout of work. This position is based on-site, in a fast-paced and dynamic setting, requiring adaptability and quick thinking.In this position, you will exemplify our Company's leadership qualities by demonstrating integrity in all interactions, fostering a culture of innovation by encouraging creative solutions within your team, and embracing collaboration across functions to achieve common goals. You will hold yourself and your team accountable for delivering results, while also considering the long-term impacts of your decisions on our community and the environment. Additionally, you will champion diversity and inclusion by building a well-rounded team of subject matter experts, ensuring multiple perspectives contribute to our manufacturing processes.**Key Responsibilities**:* Manage and mentor a team of process engineers specializing in bioprocess manufacturing for large molecules (vaccines and biologics).* Drive operational excellence for right-first-time (RFT) batch execution on the manufacturing floor.* Collaborate with cross-functional teams to ensure agile pipeline deliverables are met* Manage end to end timelines of clinical campaigns coming in and out of the pilot plant through preparation, execution, and close out**Education Minimum Requirement:**Bachelor's degree or Master's degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry.**Required Experience and Skills**:* A highly motivated individual with the ability to work in a fast-paced and dynamic environment* Demonstrated ability to mentor team members and influence cross-functional groups* Technical knowledge of fermentation and cell culture processes, including aseptic techniques, live virus handling, BSL2 practices, cleanroom protocols, and/or bioprocessing equipment* Technical knowledge in purification processes such as chromatography, tangential flow filtration (TFF), and/or dead-end filtration* Knowledge of the considerations required for transitioning from development to GMP (Good Manufacturing Practice) environments and influencing necessary adaptations* Strong understanding of cGMP (current Good Manufacturing Practices), quality systems, and safety protocols within operations* Hands on bioprocess experience either through labs or operations* Previous experience in leading projects in either process development or GMP environments**Preferred Experience and Skills**:* Excellent organizational and problem-solving abilities* Capability to work both independently and collaboratively, delivering strong results* Exceptional conflict management and negotiation skills* Strong communication skills paired with personnel development aptitude* Prior management experience, or experience leading teams* Experience with SAP inventory management system and/or SAP QN* Demonstration of Decision Making, Execution Excellence, Innovation, and Change Catalyst Leadership Skills**Required Skills:**Adaptability, Biopharmaceutical Industry, Cell Cultures, Chemical Engineering, Data-Driven Decision Making, Fast-Paced Environments, Good Manufacturing Practices (GMP), Mammalian Cell Culture, Manufacturing, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence, Process Optimization, Safety Compliance, Safety Protocols, SAP Inventory Management, Strategic Thinking, Tangential Flow Filtration (TFF), Technical Mentoring, Technical Writing**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**US and Puerto Rico Residents Only:**Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please
if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.**U.S. Hybrid Work Model**Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The salary range for this role is$142,400.00 - $224,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.
Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available #J-18808-Ljbffr